Approved Medicines

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Drug Approvals and Informations

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2017 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.
Find out more about the types of drugs included in this listing.

Cardiology/Vascular Diseases

Bevyxxa (betrixaban); Portola Pharmaceuticals; For the the prophylaxis of venous thromboembolism, Approved June 2017

Dermatology

Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017

Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017

Dupixent (dupilumab); Regeneron Pharmaceuticals; For the treatment of atopic dermatitis, Approved March 2017

Rhofade (oxymetazoline hydrochloride); Allergan; For the treatment of facial erythema associated with rosacea, Approved January 2017

Siliq (brodalumab); Valeant Pharmaceuticals; For the treatment of plaque psoriasis , Approved February 2017

Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017

Endocrinology

Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017

Family Medicine

Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017

Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Gastroenterology

Symproic (naldemedine); Shionogi; For the treatment of opioid-induced constipation, Approved March 2017

Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017

Genetic Disease

Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Hematology

Aliqopa (copanlisib); Bayer; For the treatment of follicular lymphoma , Approved September 2017

Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017

Endari (L-glutamine oral powder); Emmaus Life Sciences; For the treatment of sickle cell disease , Approved July 2017

IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017

Kymriah (tisagenlecleucel); Novartis; For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , Approved August 2017

Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017

Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017

Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017

Hepatology (Liver, Pancreatic, Gall Bladder)
Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Immunology

Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) ; CSL Behring; For the routine prophylaxis to prevent Hereditary Angioedema attacks, Approved June 2017

Actemra (tocilizumab) injection; Genentech; For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 2017

Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017

Tremfya (guselkumab); Janssen Biotech; For the treatment of moderate-to-severe plaque psoriasis, Approved July 2017

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) ; Gilead; For the treatment of hepatitis C, Approved July 2017

Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Infections and Infectious Diseases

Baxdela (delafloxacin) tablets and injection; Melinta Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved June 2017

Benznidazole; Chemo Group; For the treatment of Chagas disease , Approved August 2017

KedRab [Rabies Immune Globulin (Human)]; Kedrion Biopharma ; For the post-exposure prophylaxis of rabies infection, Approved August 2017

Mavyret (glecaprevir and pibrentasvir) ; AbbVie; For the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6, Approved August 2017

Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , Approved September 2017

Vabomere (meropenem and vaborbactam); The Medicines Company; For the treatment of complicated urinary tract infections , Approved August 2017

Internal Medicine

Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017

Musculoskeletal

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017

Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017

Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017

Ocrevus (ocrelizumab); Genentech; For the treatment of multiple sclerosis, Approved March 2017

Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017

Nephrology

Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

Neurology

Austedo (deutetrabenazine) ; Teva Pharmaceuticals; For the treatment of chorea associated with Huntington’s disease and tardive dyskinesia , Initial approval April 2017

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Gocovri (amantadine) ; Adamas Pharmaceuticals; For the treatment of Parkinson’s disease dyskinesia, Approved August 2017

Ingrezza (valbenazine); Neurocrine Biosciences; For the treatment of tardive dyskinesia, Approved April 2017

Radicava (edaravone); Mitsubishi Tanabe Pharma; For the treatment of amyotrophic lateral sclerosis , Approved May 2017

Xadago (safinamide); Newron Pharmaceuticals; For the treatment of Parkinson’s disease, Approved March 2017

Obstetrics/Gynecology (Women’s Health)
Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017

Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , Approved September 2017

Tymlos (abaloparatide) ; Radius Health; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved April 2017

Verzenio (abemaciclib); Eli Lilly; For the treatment of HR+, HER2- breast cancer, Approved September 2017

Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Oncology

Aliqopa (copanlisib); Bayer; For the treatment of follicular lymphoma , Approved September 2017

Alunbrig (brigatinib); Ariad Pharmaceuticals; For the treatment of advanced ALK-positive metastatic non-small cell lung cancer, Approved April 2017

Bavencio (avelumab) ; EMD Serono/Pfizer; For the treatment of Merkel cell carcinoma , Approved March 2017

Besponsa (inotuzumab ozogamicin); Pfizer; For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Approved August 2017

IDHIFA (enasidenib); Celgene; For the treatment of relapsed or refractory acute myeloid leukemia with IDH2 mutation , Approved August 2017

Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma, Approved May 2017

Kisqali (ribociclib); Novartis; For the treatment of breast cancer, Approved March 2017

Kymriah (tisagenlecleucel); Novartis; For the treatment of refractory B-cell precursor acute lymphoblastic leukemia , Approved August 2017

Nerlynx (neratinib); Puma Biotech; For the treatment of HER2 breast cancer, Approved July 2017

Rydapt (midostaurin); Novartis; For the treatment of FLT3 positive acute myeloid leukemia and mastocytosis , Approved April 2017

Verzenio (abemaciclib); Eli Lilly; For the treatment of HR+, HER2- breast cancer, Approved September 2017

Vyxeos (daunorubicin and cytarabine) ; Jazz Pharma; For the treatment of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes, Approved August 2017

Xermelo (telotristat ethyl); Lexicon Pharmaceuticals; For the treatment of carcinoid syndrome diarrhea, Approved February 2017

Zejula (niraparib); Tesaro; For the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer , Approved March 2017

Ophthalmology

Zerviate (cetirizine ophthalmic solution 0.24%); NicOx; For the treatment of ocular itching associated with allergic conjunctivitis, Approved May 2017

Pediatrics/Neonatology

Brineura (cerliponase alfa); BioMarin; For the treatment of late infantile neuronal ceroid lipofuscinosis type 2 , Approved April 2017

Emflaza (deflazacort); Marathon Pharmaceuticals; For the treatment of Duchenne muscular dystrophy, Approved February 2017

Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) ; Novo Nordisk; For the treatment of hemophilia B, Approved June 2017

Pharmacology/Toxicology

Actemra (tocilizumab) injection; Genentech; For the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome, Approved September 2017

Gocovri (amantadine) ; Adamas Pharmaceuticals; For the treatment of Parkinson’s disease dyskinesia, Approved August 2017

Rheumatology

Duzallo (lesinurad and allopurinol) ; Ardea Biosciences; For the treatment of hyperuricemia associated with gout , Approved August 2017

Kevzara (sarilumab); Sanofi ; For the treatment of active rheumatoid arthritis, Approved May 2017

Urology

Imfinzi (durvalumab); AstraZeneca; For the treatment of advanced or metastatic urothelial carcinoma, Approved May 2017

Vabomere (meropenem and vaborbactam); The Medicines Company; For the treatment of complicated urinary tract infections , Approved August 2017

2016 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Cardiology/Vascular Diseases

Byvalson (nebivolol and valsartan); Allergan; For the treatment of hypertension, Approved June 2016

Yosprala (aspirin and omeprazole); Aralez Pharmaceuticals; For the prevention of cardiovascular and cerebrovascular events, Approved September 2016

Dermatology

Ameluz (aminolevulinic acid hydrochloride); Biofrontera Pharma; For the treatment of actinic keratoses, Approved May 2016

Eucrisa (crisaborole) ointment; Pfizer; For the treatment of atopic dermatitis, Approved December 2016

Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis, Approved March 2016

Endocrinology

Adlyxin (lixisenatide); Sanofi Aventis; For the treatment of type II diabetes, Approved July 2016

Soliqua 100/33 (insulin glargine and lixisenatide injection); Sanofi Aventis; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Xultophy 100/3.6 (insulin degludec and liraglutide injection); Novo Nordisk; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Family Medicine

Byvalson (nebivolol and valsartan); Allergan; For the treatment of hypertension, Approved June 2016

Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016

Soliqua 100/33 (insulin glargine and lixisenatide injection); Sanofi Aventis; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Xultophy 100/3.6 (insulin degludec and liraglutide injection); Novo Nordisk; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Gastroenterology

Zinplava (bezlotoxumab); Merck; For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment, Approved October 2016

Genetic Disease

Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Hematology

Afstyla (Antihemophilic Factor (Recombinant), Single Chain); CSL Behring; For the treatment of hemophillia A, Approved May 2016

Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein); CSL Behring; For the treatment of hemophilia B, Approved March 2016

Kovaltry [Antihemophilic Factor (Recombinant)]; Bayer ; For the treatment of hemophillia A, Approved March 2016

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of classical Hodgkin lymphoma, Approved May 2016

Venclexta (venetoclax); AbbVie; For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016

Hepatology (Liver, Pancreatic, Gall Bladder)

Defitelio (defibrotide sodium); Jazz Pharmaceuticals; For the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following HSCT, Approved March 2016

Ocaliva (obeticholic acid); Intercept Pharmaceuticals; For the treatment of primary biliary cholangitis, Approved May 2016

Vemlidy (tenofovir alafenamide); Gilead Sciences; For the treatment of chronic hepatitis B , Approved November 2016

Zepatier (elbasvir and grazoprevir); Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016

Immunology

Afstyla (Antihemophilic Factor (Recombinant), Single Chain); CSL Behring; For the treatment of hemophillia A, Approved May 2016

Descovy (emtricitabine and tenofovir alafenamide); Gilead; For the treatment of HIV-1 infection, Approved April 2016

Epclusa (sofosbuvir and velpatasvir) ; Gilead Sciences; For the treatment of hepatitis C, Approved June 2016

Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 as initial therapy, Approved March 2016

Taltz (ixekizumab); Eli Lilly; For the treatment of plaque psoriasis, Approved March 2016

Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016

Infections and Infectious Diseases

Anthim (obiltoxaximab); Elusys Therapeutics; For the treatment of inhalational anthrax , Approved March 2016

Descovy (emtricitabine and tenofovir alafenamide); Gilead; For the treatment of HIV-1 infection, Approved April 2016

Epclusa (sofosbuvir and velpatasvir) ; Gilead Sciences; For the treatment of hepatitis C, Approved June 2016

Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 as initial therapy, Approved March 2016

Syndros (dronabinol oral solution); Insys Therapeutics; For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016

Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016

Vemlidy (tenofovir alafenamide); Gilead Sciences; For the treatment of chronic hepatitis B , Approved November 2016

Zepatier (elbasvir and grazoprevir); Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016

Zinplava (bezlotoxumab); Merck; For the treatment of recurrent Clostridium difficile infection in patients receiving antibacterial treatment, Approved October 2016

Musculoskeletal

Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016

Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Zinbryta (daclizumab) ; Biogen; For the treatment of relapsing multiple sclerosis, Approved May 2016

Nephrology

Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016

Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016

Rayaldee (calcifediol) ; Opko Health; For the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, Approved June 2016

Neurology

Briviact (brivaracetam); UCB; For the treatment of partial onset seizures related to epilepsy, Approved February 2016

Carnexiv (carbamazepine); Lundbeck; replacement therapy when oral administration is not feasible, in adults with seizures, Approved October 2016

Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016

Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease, Approved April 2016

Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016

Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016

Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Troxyca ER (oxycodone + naltrexone); Pfizer; For the management of severe pain, Approved August 2016

Zinbryta (daclizumab) ; Biogen; For the treatment of relapsing multiple sclerosis, Approved May 2016

Obstetrics/Gynecology (Women’s Health)

Intrarosa (prasterone vaginal insert); Endoceutics; For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause, Approved November 2016

Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016

Oncology

Cabometyx (cabozantinib); Exelixis; For the treatment of advanced renal cell carcinoma, Approved April 2016

Keytruda (pembrolizumab); Merck; For the treatment of head and neck squamous cell cancer , Approved August 2016

Lartruvo (olaratumab) ; Eli Lilly; For the treatment of soft tissue sarcoma, Approved October 2016

Lenvima (lenvatinib); Eisai; For the treatment of advanced renal cell carcinoma, Approved May 2016

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of classical Hodgkin lymphoma, Approved May 2016

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck, Approved November 2016

Rubraca (rucaparib); Clovis Oncology; For the treatment of advanced ovarian cancer in women with deleterious germline or somatic BRCA mutation, Approved December 2016

Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016

Syndros (dronabinol oral solution); Insys Therapeutics; For the treatment of anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy, Approved July 2016

Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

Venclexta (venetoclax); AbbVie; For the treatment of chronic lymphocytic leukemia with 17p deletion, Approved April 2016

Ophthalmology

Humira (adalimumab); Abbvie; For the treatment of uveitis, Approved July 2016

Xiidra (lifitegrast); Shire; For the treatment of dry eye disease, Approved July 2016

Pediatrics/Neonatology

Exondys 51 (eteplirsen); Sarepta Therapeutics; For the treatment of Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping, Approved September 2016

Kovaltry [Antihemophilic Factor (Recombinant)]; Bayer ; For the treatment of hemophillia A, Approved March 2016

Spinraza (nusinersen); Biogen; For the treatment of spinal muscular atrophy, Approved December 2016

Pharmacology/Toxicology

Sustol (granisetron); Heron Therapeutics; For the prevention of chemotherapy-induced nausea and vomiting, Approved August 2016

Psychiatry/Psychology

Nuplazid (pimavanserin); Acadia Pharmaceuticals; For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, Approved May 2016

Pulmonary/Respiratory Diseases

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate); AstraZeneca; For the treatment of chronic obstructive pulmonary disease, Approved April 2016

Cinqair (reslizumab); Teva Pharmaceuticals; For the treatment of severe asthma, Approved March 2016

Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

Urology

Tecentriq (atezolizumab); Genentech; For the treatment of urothelial carcinoma and metastatic non-small cell lung cancer, Approved May 2016

Vaccines

Vaxchora (Cholera Vaccine, Live, Oral); PaxVax; For active immunization against Cholera, Approved June 2016

2015 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Cardiology/Vascular Diseases

Corlanor (ivabradine); Amgen; For the treatment of chronic heart failure, Approved April 2015

Entresto (sacubitril and valsartan); Novartis; For the treatment of chronic heart failure, Approved July 2015

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Kengreal (cangrelor) ; The Medicines Company; For reducing periprocedural thrombotic events, Approved June 2015

Praluent (alirocumab); Sanofi Aventis; For the treatment of heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, Approved July 2015

Prestalia (perindopril arginine and amlodipine besylate); Symplmed Pharmaceuticals; For the treatment of hypertension, Approved January 2015

Repatha (evolocumab) ; Amgen; For the treatment of high cholesterol, Approved August 2015

Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015

Uptravi (selexipag); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved December 2015

Dermatology

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Endocrinology

Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015

Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015

Synjardy (empagliflozin and metformin hydrochloride) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2015

Tresiba (insulin degludec injection); Novo Nordisk; For glycemic control in adults with diabetes mellitus, Approved September 2015

Family Medicine

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015

Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015

Gastroenterology

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015

Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015

Genetic Disease

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Xuriden (uridine triacetate); Wellstat Therapeutics; For the treatment of hereditary orotic aciduria, Approved September 2015

Hematology

Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015

Nuwiq (recombinant Factor VIII); Octapharma; For the prophylaxis and treatment of hemophilia A, Approved September 2015

Praxbind (idarucizumab); Boehringer Ingelheim; For the reversal of the anticoagulant effects of dabigatran, Approved October 2015

Veltassa (patiromer); Relypsa; For the treatment of hyperkalemia, Approved October 2015

Hepatology (Liver, Pancreatic, Gall Bladder)

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015

Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015

Immunology

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015

Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015

Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015

Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015

Infections and Infectious Diseases

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015

Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015

Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015

Fluad (trivalent influenza vaccine); Seqirus; For the prevention of influenza A and B, Approved November 2015

Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015

Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015

Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015

Musculoskeletal

Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015

Nephrology

Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of advanced renal cell carcinoma, Approved November 2015

Zurampic (lesinurad); AstraZeneca; For the treatment of hyperuricemia associated with gout , Approved December 2015

Neurology

Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015

Belbuca (buprenorphine) ; Endo Pharmaceuticals; For the management of severe pain, Approved October 2015

Duopa (carbidopa and levodopa) enteral suspension ; Abbvie; For the treatment of motor fluctuations in patients with advanced Parkinson’s disease, Approved January 2015

Rytary (carbidopa and levodopa) extended-release capsules; Impax Labs; For the treatment of Parkinson’s disease, Approved January 2015

Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015

Vraylar (cariprazine); Allergan; For the treatment of schizophrenia and bipolar disorder, Approved September 2015

Obstetrics/Gynecology (Women’s Health)

Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Oncology

Alecensa (alectinib); Roche; For the treatment of ALK-positive, metastatic non-small cell lung cancer , Approved December 2015

Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015

Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015

Empliciti (elotuzumab); Bristol-Myers Squibb; For the treatment of patients with multiple myeloma who have received prior therapies, Approved November 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015

Keytruda (pembrolizumab); Merck; For the treatment of PD-L1 positive advanced non-small cell lung cancer, Approved October 2015

Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Ninlaro (ixazomib); Millennium Pharmaceuticals; For the treatment of multiple myeloma, Approved November 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of advanced renal cell carcinoma, Approved November 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Portrazza (necitumumab) ; Eli Lilly; For the treatment of metastatic squamous non-small cell lung cancer, Approved November 2015

Tagrisso (osimertinib); AstraZeneca; For the treatment of EGFR T790M mutation positive non-small cell lung cancer , Approved November 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015

Vistogard (uridine triacetate); Wellstat Therapeutics; For the emergency treatment of patients with a fluorouracil or capecitabine overdose, Approved December 2015

Yondelis (trabectedin); Janssen; For the treatment of liposarcoma or leiomyosarcoma, Approved October 2015

Orthopedics/Orthopedic Surgery

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Otolaryngology (Ear, Nose, Throat)

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Pediatrics/Neonatology

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015

Kanuma (sebelipase alfa); Alexion; For the treatment of Lysosomal Acid Lipase (LAL) deficiency, Approved December 2015

Orkambi (lumacaftor and ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis, Approved July 2015

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Pharmacology/Toxicology

Bridion (sugammadex); Merck; For the reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery, Approved December 2015

Psychiatry/Psychology

Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015

Rexulti (brexpiprazole); Otsuka; For the treatment of depression and schizophrenia, Approved July 2015

Vraylar (cariprazine); Allergan; For the treatment of schizophrenia and bipolar disorder, Approved September 2015

Pulmonary/Respiratory Diseases

Alecensa (alectinib); Roche; For the treatment of ALK-positive, metastatic non-small cell lung cancer , Approved December 2015

Keytruda (pembrolizumab); Merck; For the treatment of PD-L1 positive advanced non-small cell lung cancer, Approved October 2015

Nucala (mepolizumab); GlaxoSmithKline; For the treatment of severe asthma with an eosinophilic phenotype, Approved November 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Orkambi (lumacaftor and ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis, Approved July 2015

Portrazza (necitumumab) ; Eli Lilly; For the treatment of metastatic squamous non-small cell lung cancer, Approved November 2015

Stiolto Respimat (tiotropium bromide and olodaterol) ; Boehringer Ingelheim; For the maintenance of chronic obstructive pulmonary disease, Approved May 2015

Tagrisso (osimertinib); AstraZeneca; For the treatment of EGFR T790M mutation positive non-small cell lung cancer , Approved November 2015

Utibron Neohaler (indacaterol and glycopyrrolate); Novartis; For the long term, maintenance treatment of airflow obstruction in patients with COPD, Approved October 2015

Urology

Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015

Xuriden (uridine triacetate); Wellstat Therapeutics; For the treatment of hereditary orotic aciduria, Approved September 2015

Vaccines

Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015

2014 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Cardiology/Vascular Diseases

Epanova (omega-3-carboxylic acids); AstraZeneca; For the treatment of severe hypertriglyceridemia, Approved May 2014

Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014

Dermatology

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014

Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin structure infections, Approved August 2014

Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved September 2014

Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014

Soolantra (ivermectin) cream, 1%; Galderma Labs; For the treatment of inflammatory lesions of rosacea, Approved December 2014

Endocrinology

Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014

Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014

Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of endogenous testosterone, Approved May 2014

Signifor LAR (pasireotide); Novartis; For the treatment of acromegaly, Approved December 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September 2014

Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous testosterone, Approved June 2014

Xigduo XR (dapagliflozin + metformin hydrochloride); AstraZeneca; For glycemic control in adults with type II diabetes, Approved October 2014

Family Medicine

Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma, Approved August 2014

Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.; For chronic weight management , Approved September 2014

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain, Approved December 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn’s disease, Approved May of 2014

Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of endogenous testosterone, Approved May 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved September 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Rapivab (peramivir injection); Biocryst; For the treatment of acute uncomplicated influenza in adults, Approved December 2014

Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved December 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Xtoro (finafloxacin otic suspension) 0.3%; Alcon; For the treatment of acute otitis externa, Approved December 2014

Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014

Gastroenterology

Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn’s disease, Approved May of 2014

Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014

Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014

Genetic Disease

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Healthy Volunteers

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Hematology

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014

Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; Biogen IDEC.; For the treatment of hemophillia A, Approved June 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia and Waldenstrom macroglobulinemia, Approved February 2014

Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence]; Baxter; For the treatment of acquired hemophilia A, Approved October 2014

Ruconest (C1 esterase inhibitor [recombinant]); Pharming Group; For the treatment of hereditary angioedema, Approved July 2014

Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved April 2014

Zontivity (vorapaxar); Merck; For the reduction of thrombotic cardiovascular events, Approved May 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Immunology

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn’s disease, Approved May of 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]; Baxter; For the treatment of Primary Immunodeficiency, Approved September 2014

Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved September 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Sylvant (siltuximab); Janssen Biotech; For the treatment of multicentric Castleman’s disease, Approved April 2014

Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare; For the treatment of HIV-1, Approved August 2014

Infections and Infectious Diseases

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Harvoni (ledipasvir and sofosbuvir); Gilead; For the treatment of hepatitis C, Approved October 2014

Impavido (miltefosine); Knight Therapeutics; For the treatment of visceral, cutaneous and mucosal leishmaniasis, Approved March 2014

Jublia (efinaconazole) 10% topical gel; Valeant Pharmaceuticals; For the treatment of onychomycosis of the toenails, Approved June 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Orbactiv (oritavancin); The Medicines Company; For the treatment of acute bacterial skin and skin structure infections, Approved August 2014

Rapivab (peramivir injection); Biocryst; For the treatment of acute uncomplicated influenza in adults, Approved December 2014

Sivextro (tedizolid phosphate) ; Cubist Pharmaceuticals; For the treatment of acute bacterial skin and skin structure infections, Approved June 2014

Triumeq (abacavir, dolutegravir, and lamivudine); ViiV HealthCare; For the treatment of HIV-1, Approved August 2014

Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie; For the treatment of genotype 1 chronic hepatitis C virus, Approved December 2014

Xtoro (finafloxacin otic suspension) 0.3%; Alcon; For the treatment of acute otitis externa, Approved December 2014

Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014

Internal Medicine

Cerdelga (eliglustat); Genzyme; For the treatment of certain adult patients with Gaucher disease type 1, Approved August 2014

Musculoskeletal

Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved November 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Nephrology

Auryxia (Ferric citrate); Keryx Biopharma; For the treatment of hyperphosphatemia in patients with chronic kidney disease, Approved September 2014

Harvoni (ledipasvir and sofosbuvir); Gilead; For the treatment of hepatitis C, Approved October 2014

Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; Abbvie; For the treatment of genotype 1 chronic hepatitis C virus, Approved December 2014

Neurology

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain, Approved December 2014

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved November 2014

Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014

Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimer’s type, Approved December 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Nutrition and Weight Loss

Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.; For chronic weight management , Approved September 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved December 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September 2014

Obstetrics/Gynecology (Women’s Health)
Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Oncology

Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia and Waldenstrom macroglobulinemia, Approved February 2014

Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014

Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Ophthalmology

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Omidria (phenylephrine and ketorolac injection); Omeros; For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain, Approved June 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Orthopedics/Orthopedic Surgery

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Otolaryngology (Ear, Nose, Throat)

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Xtoro (finafloxacin otic suspension) 0.3%; Alcon; For the treatment of acute otitis externa, Approved December 2014

Pediatrics/Neonatology

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Pharmacology/Toxicology

Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Psychiatry/Psychology

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Pulmonary/Respiratory Diseases

Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma, Approved August 2014

Esbriet (pirfenidone); InterMune; For the treatment of idiopathic pulmonary fibrosis , Approved October 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Incruse Ellipta (umeclidinium inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2014

Ofev (nintedanib); Boehringer Ingelheim; For the treatment of idiopathic pulmonary fibrosis , Approved October 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Striverdi Respimat (olodaterol); Boehringer Ingelheim; For the treatment of chronic obstructive pulmonary disease , Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Rheumatology

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Sleep

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Urology

Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014

2013 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Cardiology/Vascular Diseases

Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved October 2013

Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November 2013

Dermatology

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013

Mirvaso (brimonidine); Galderma Labs; For the treatment of facial erythema of rosacea, Approved August 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November 2013

Devices

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Endocrinology

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Family Medicine

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie’s disease, Approved December of 2013

Gastroenterology

Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Genetic Disease

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 2013

Healthy Volunteers

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Hematology

Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic leukemia, Approved October of 2013

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 2013

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013

Rixubis (Coagulation Factor IX (Recombinant)]; Baxter International; For the routine prophylaxis and control of hemophilia B, Approved June 2013

Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Hepatology (Liver, Pancreatic, Gall Bladder)

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013

Immunology

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Infections and Infectious Diseases

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013

Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013

Musculoskeletal

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Nephrology

Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia, Approved July 2013

Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013

Neurology

Aptiom (eslicarbazepine acetate); Sunovion Pharmaceuticals; For the adjunctive treatment of partial-onset seizures, Approved November 2013

Fetzima (levomilnacipran); Forest Laboratories; For the treatment of major depressive disorder, Approved July 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013

Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules; Zogenix; For the management of severe pain, Approved October 2013

Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013

Nutrition and Weight Loss

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Obstetrics/Gynecology (Women’s Health)

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott; For the prevention of pregnancy, Approved July 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Oncology

Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic leukemia, Approved October of 2013

Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 2013

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Orthopedics/Orthopedic Surgery

Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013

Pediatrics/Neonatology

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013

Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013

Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013

Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12 years of age, Approved August 2013

Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013

Pharmacology/Toxicology

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Podiatry

Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, November of 2013

Psychiatry/Psychology

Brintellix (vortioxetine); Takeda Pharmaceuticals USA; For the treatment of Major Depressive Disorder, Approved October 2013

Fetzima (levomilnacipran); Forest Laboratories; For the treatment of major depressive disorder, Approved July 2013

Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013

Pulmonary/Respiratory Diseases

Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October 2013

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial hypertension, Approved October 2013

Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus, Approved June 2013

Rheumatology

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Trauma (Emergency, Injury, Surgery)

Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013

Urology

Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie’s disease, Approved December of 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Vaccines

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013