HIV Tablets Dolutegravir and Rilpivirine Get Tentative Approval from US FDA

On Monday, January 16, 2023, a transnational Pharmaceutical firm named Lupin, announced that it had received a tentative nod from the US health regulator (FDA) to market its generic version of fixed-dose combination antiretroviral medication Dolutegravir and Rilpivirine tablets widely used for the treatment of HIV/AIDS.

The tentative approval granted by the US FDA is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, to market a generic equivalent of Juluca Tablets, 50 mg/25 mg (Juluca is a prescription medicine that is used without other antiretroviral (ARV) medicines to treat HIV-1 infection in adult patients to replace their ongoing anti-HIV-1 medicines when their health specialist determines that they meet certain requirements).

The Dolutegravir and Rilpivirine 50 mg/25 mg, two-drug single-tablet regimen (STR), had estimated yearly sales of 666 Million USD in the US, the company said citing IQVIA MAT September 2022 data.

About Dolutegravir and Rilpivirine:

Dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and Rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), specifically is a two-drug combination, approved as a complete regimen to treat HIV-1 infection in adult patients to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA below 50 copies/mL) on a stable antiretroviral (ARV) regimen for at least 6 months with no history of treatment failure and no known substitutions linked with resistance to the medicine Dolutegravir/Rilpivirine.

Dosage Form & Strength: Each tablet typically contains: 50 mg of dolutegravir (which is equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (which is equivalent to 27.5 mg rilpivirine hydrochloride).

Side Effects: The most commonly reported adverse reactions (all grades) observed in at least 2 percent of subjects are headache, diarrhea, and nausea.

Reference link: https://health.economictimes.indiatimes.com/news/pharma/us-fda-approves-lupin-for-dolutegravir-and-rilpivirine-tablets/97028192?action=profile_completion&utm_source=Mailer&utm_medium=newsletter&utm_campaign=ethealth_news_2023-01-17&dt=2023-01-17&em=aWtyaXNjb250ZW50QGdtYWlsLmNvbQ==