Prezcobix FDA Approval History
FDA Approved: Yes (First approved January 29, 2015)
Brand name: Prezcobix
Generic name: cobicistat and darunavir
Dosage form: Tablets
Company: Johnson & Johnson Innovative Medicine
Treatment for: HIV Infection
Prezcobix (darunavir and cobicistat) is a protease inhibitor and pharmacokinetic enhancer combination for the treatment of HIV-1 infection.
- Prezcobix is a two-drug combination of darunavir (a human immunodeficiency virus (HIV-1) protease inhibitor) and cobicistat (a CYP3A inhibitor) that is indicated for the treatment of HIV-1 in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 25 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Development timeline for Prezcobix
| Date | Article |
|---|---|
| Jan 29, 2015 | Approval FDA Approves Prezcobix (darunavir and cobicistat) for HIV-1 Infection in Adults |
| Apr 1, 2014 | Janssen Submits NDA for a Fixed-Dose Combination of Darunavir with Cobicistat |
Further information
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