Treats no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V…. NDA 220092, held by Janssen Prods. Cobicistat; Darunavir Ethanolate, Darunavir And Cobicistat.
As of Nov 14, 2026, NDA 220092 (Prezcobix Ped, Prezcobix), held by Janssen Prods, was first approved by FDA on Feb 27, 2026, with 0 approved supplements and 0 published complete response letters.
PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2026 | Original applicationNew dosage form · Standard review | Approved |
| Prezcobix Ped90MG;EQ 600MG BASE · tablet, for suspension;oral | Cobicistat; Darunavir Ethanolate | RxReference drug |
| Prezcobix675MG/150MG · tablet, for suspension;oral | Darunavir And Cobicistat | Rx |
| Prezcobix600MG/90MG · tablet, for suspension;oral | Darunavir And Cobicistat | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
