Prezcobix

Treats no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V…. NDA 205395, held by Janssen Prods. Cobicistat; Darunavir Ethanolate.

As of Nov 15, 2026, NDA 205395 (Prezcobix), held by Janssen Prods, was first approved by FDA on Jan 29, 2015, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2015
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Feb 27, 2026	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 21, 2025	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 31, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 4, 2018	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 29, 2015	Original applicationNew combination · Priority review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Prezcobix150MG;EQ 800MG BASE · tablet;oral	Cobicistat; Darunavir Ethanolate	RxReference drug
Prezcobix150MG;EQ 675MG BASE · tablet;oral	Cobicistat; Darunavir Ethanolate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Feb 27, 2026	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 21, 2025	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 31, 2023	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 20, 2022	Supplement 24Labeling · Standard review	Approved	Label Letter
Apr 14, 2022	Supplement 22Labeling · Standard review	Approved	Label Letter
Jul 23, 2021	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 22, 2020	Supplement 18Labeling · Standard review	Approved	Label Letter
Jul 31, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 29, 2019	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 28, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 7, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 4, 2018	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 25, 2018	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 25, 2018	Supplement 6Labeling · Standard review	Approved	Label Letter
Jun 14, 2017	Supplement 4Labeling · Standard review	Approved	Label Letter
Sep 22, 2016	Supplement 2Labeling · Standard review	Approved	Letter Label
Mar 31, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 29, 2015	Original applicationNew combination · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 205395
Drugs@FDA: Overview at FDA
Company: Janssen Products

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