Prezista

Treats human immunodeficiency virus (HIV-1) infection. NDA 202895, held by Janssen Prods. Darunavir.

As of Nov 13, 2026, NDA 202895 (Prezista), held by Janssen Prods, was first approved by FDA on Dec 16, 2011, with 27 approved supplements and 0 published complete response letters.

First approved: Dec 16, 2011
Review: Priority
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older. PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Mar 21, 2019	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 24, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2013	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 1, 2013	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 16, 2011	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prezista100MG/ML · suspension;oral	Darunavir	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Mar 31, 2023	Supplement 36Labeling · Standard review	Approved	Label Letter
Oct 20, 2022	Supplement 35Labeling · Standard review	Approved	Label Letter
Apr 14, 2022	Supplement 34Labeling · Standard review	Approved	Letter Label
Aug 17, 2021	Supplement 32Labeling · Standard review	Approved	Letter
Jul 23, 2021	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 22, 2020	Supplement 29Labeling · Standard review	Approved	Label Letter
May 28, 2019	Supplement 27Labeling · Standard review	Approved	Letter Label
Mar 21, 2019	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 31, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 7, 2018	Supplement 22Labeling · Standard review	Approved	Letter
Jan 25, 2018	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 19, 2017	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 17, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 27, 2015	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 27, 2015	Supplement 16Labeling	Approved	Label Letter
May 8, 2014	Supplement 12Manufacturing · Priority review	Approved	None posted
Apr 7, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Nov 7, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 24, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 22, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Feb 1, 2013	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 1, 2013	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 9, 2012	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 1, 2012	Supplement 2Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 16, 2011	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202895
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