Prezista

Treats human immunodeficiency virus (HIV-1) infection. NDA 21976, held by Janssen Prods. Darunavir.

As of Nov 15, 2026, NDA 21976 (Prezista), held by Janssen Prods, was first approved by FDA on Jun 23, 2006, with 48 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2006
Review: Priority
Supplements approved: 48
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 49 submissions below


Mar 21, 2019	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2016	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 24, 2013	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2013	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 1, 2013	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 16, 2011	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Oct 19, 2011	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 13, 2010	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2010	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 18, 2008	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 21, 2008	Supplement 6Efficacy (new indication or use)	Approved	Letter
Oct 21, 2008	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Jun 23, 2006	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter Pediatric Medical Review

Products

6 strengths and forms


Prezista300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Darunavir	DiscontinuedReference drug
Prezista600MG · tablet;oral	Darunavir	RxReference drug
Prezista400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Darunavir	DiscontinuedReference drug
Prezista75MG · tablet;oral	Darunavir	RxReference drug
Prezista150MG · tablet;oral	Darunavir	RxReference drug
Prezista800MG · tablet;oral	Darunavir	RxReference drug

All 49 submissions, including labeling and manufacturing supplements


Mar 31, 2023	Supplement 68Labeling · Standard review	Approved	Label
Oct 20, 2022	Supplement 67Labeling · Standard review	Approved	Label Letter
Apr 14, 2022	Supplement 65Labeling · Standard review	Approved	Letter Label
Aug 17, 2021	Supplement 63Labeling · Standard review	Approved	Label Letter
Jul 23, 2021	Supplement 62Labeling · Standard review	Approved	Letter Label
Dec 22, 2020	Supplement 59Labeling · Standard review	Approved	Label Letter
May 28, 2019	Supplement 56Labeling · Standard review	Approved	Letter Label
Mar 21, 2019	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 31, 2019	Supplement 54Labeling · Standard review	Approved	Letter Label
Sep 7, 2018	Supplement 51Labeling · Standard review	Approved	Letter Label
Jan 25, 2018	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 19, 2017	Supplement 45Labeling · Standard review	Approved	Label Letter
Sep 15, 2016	Supplement 44Labeling	Approved	Letter Label
Jun 17, 2016	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 11, 2016	Supplement 42Manufacturing · Priority review	Approved	None posted
Feb 19, 2016	Supplement 38Manufacturing · Priority review	Approved	None posted
May 27, 2015	Supplement 36Labeling · Standard review	Approved	Label Letter
Mar 27, 2015	Supplement 39Labeling	Approved	Label Letter
Feb 3, 2015	Supplement 37Manufacturing · Priority review	Approved	None posted
May 8, 2014	Supplement 35Manufacturing · Priority review	Approved	None posted
Apr 7, 2014	Supplement 34Labeling · Standard review	Approved	Label Letter
Nov 7, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Oct 31, 2013	Supplement 32Manufacturing · Priority review	Approved	None posted
Jun 14, 2013	Supplement 31Manufacturing · Priority review	Approved	None posted
Apr 24, 2013	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 22, 2013	Supplement 30Labeling · Standard review	Approved	Label Letter
Feb 1, 2013	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 1, 2013	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 9, 2012	Supplement 25Manufacturing · Priority review	Approved	Label
Jun 1, 2012	Supplement 26Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 22Labeling	Approved	Label Letter
Feb 13, 2012	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Oct 19, 2011	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 13, 2010	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 26, 2010	Supplement 16Labeling	Approved	Label Letter
Jan 27, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2010	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 15, 2009	Supplement 10Labeling · Standard review	Approved	Label Letter
Jun 15, 2009	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 18, 2008	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 21, 2008	Supplement 6Efficacy (new indication or use)	Approved	Letter
Oct 21, 2008	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Mar 7, 2008	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 7, 2008	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 25, 2008	Supplement 5Manufacturing · Priority review	Approved	Letter Label
Apr 25, 2007	Supplement 2Manufacturing	Approved	None posted
Nov 20, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 23, 2006	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter Pediatric Medical Review

Identifiers

Application: NDA 21976
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