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FDA Approved Drugs

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Vanflyta (Quizartinib dihydrochloride)

Treatment For: Acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive

Manufactured By: Daiichi Sankyo

Date Of Approval: 2023-07-20

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Ycanth (Cantharidin)

Treatment For: Molluscum contagiosum in adult and pediatric patients 2 years of age and older

Manufactured By: Verrica Pharmaceuticals

Date Of Approval: 2023-07-21

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Xdemvy (Lotilaner)

Treatment For: Demodex blepharitis

Manufactured By: Tarsus Pharmaceuticals

Date Of Approval: 2023-07-25

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Zurzuvae (Zuranolone)

Treatment For: Postpartum depression (PPD) in Adults

Manufactured By: Sage Therapeutics

Date Of Approval: 2023-08-04

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Izervay (Avacincaptad pegol sodium)

Treatment For: Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Manufactured By: Iveric bio

Date Of Approval: 2023-08-14

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Talvey (Talquetamab)

Treatment For: Relapsed or refractory multiple myeloma

Manufactured By: Janssen Biotech

Date Of Approval: 2023-08-09

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Elrexfio (Elranatamab)

Treatment For: Relapsed or refractory Multiple Myeloma

Manufactured By: Pfizer Inc.

Date Of Approval: 2023-08-14

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Sohonos (Palovarotene)

Treatment For: Reduction in the volume of new heterotopic ossification

Manufactured By: Ipsen Biopharmaceuticals

Date Of Approval: 2023-08-16

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Veopoz (Pozelimab)

Treatment For: CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

Manufactured By: Regeneron Pharmaceuticals

Date Of Approval: 2023-08-18

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Aphexda (Motixafortide acetate)

Treatment For: Mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma

Manufactured By: BioLineRx

Date Of Approval: 2023-10-08

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Ojjaara (Momelotinib dihydrochloride monohydrate)

Treatment For: Intermediate or high-risk myelofibrosis (MF)

Manufactured By: GlaxoSmithKline

Date Of Approval: 2023-10-15

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Exxua (Gepirone hydrochloride)

Treatment For: Major depressive disorder

Manufactured By: Fabre-Kramer Pharmaceuticals

Date Of Approval: 2023-10-22

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Pombiliti (Cipaglucosidase alfa)

Treatment For: Late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency)

Manufactured By: Amicus Therapeutics

Date Of Approval: 2023-10-28

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Rivfloza (Nedosiran sodium)

Treatment For: Moderately to severely active ulcerative colitis in adults

Manufactured By: Novo Nordisk

Date Of Approval: 2023-10-29

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Velsipity (Etrasimod arginine)

Treatment For: Active Ulcerative Colitis (UC) in Adults

Manufactured By: Pfizer Inc

Date Of Approval: 2023-10-12

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Zilbrysq (Zilucoplan sodium)

Treatment For: Generalized myasthenia gravis (gMG)

Manufactured By: UCB Inc

Date Of Approval: 2023-10-17

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Bimzelx (Bimekizumab)

Treatment For: Treatment of moderate to severe plaque psoriasis

Manufactured By: UCB Inc

Date Of Approval: 2023-10-17

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Agamree (Vamorolone)

Treatment For: Moderately to severely active ulcerative colitis in adults

Manufactured By: Santhera Pharmaceuticals

Date Of Approval: 2023-10-26

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Omvoh (Mirikizumab)

Treatment For: Moderately to severely active ulcerative colitis in adults

Manufactured By: Eli Lilly

Date Of Approval: 2023-10-26

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Loqtorzi (Toripalimab)

Treatment For: Metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) and h recurrent unresectable

Manufactured By: Coherus BioSciences

Date Of Approval: 2023-10-27

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Fruzaqla (Fruquintinib)

Treatment For: Adult patients with Metastatic Colorectal Cancer (mCRC)

Manufactured By: Takeda Pharmaceuticals

Date Of Approval: 2023-11-08

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Defencath (Taurolidine and Heparin)

Treatment For: Reduce the incidence of catheter-related bloodstream infections

Manufactured By: CorMedix Inc

Date Of Approval: 2023-11-15

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Augtyro (Repotrectinib)

Treatment For: Locally advanced or metastatic NSCLC

Manufactured By: Bristol-Myers Squibb

Date Of Approval: 2023-11-15

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Ryzneuta (Efbemalenograstim alfa)

Treatment For: Non-myeloid Malignancies- Decrease the incidence of infection

Manufactured By: Evive Biotechnology

Date Of Approval: 2023-11-16

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Truqap (Capivasertib)

Treatment For: Metastatic Breast Cancer

Manufactured By: AstraZeneca

Date Of Approval: 2023-11-16

Country Specific Regulations

Country-specific regulations that allow the import of unapproved medicine

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Australia

Importing a medicine that is unapproved by the Therapeutic Goods Administration (TGA) is possible under the Personal Importation Scheme.

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