Reyataz

Treats HIV-1 infection. NDA 21567, held by Bristol Myers Squibb. Atazanavir Sulfate.

As of Nov 14, 2026, NDA 21567 (Reyataz), held by Bristol Myers Squibb, was first approved by FDA on Jun 20, 2003, with 37 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2003
Review: Priority
Supplements approved: 37
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

REYATAZ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use:

REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below


May 23, 2017	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 24, 2015	Supplement 38Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Reissue Amendment 6 Pediatric Reissue Amendment 5
Jun 2, 2014	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Label Letter
Oct 17, 2011	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 4, 2011	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 5, 2009	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 30, 2008	Supplement 17Efficacy (new indication or use)	Approved	Label Letter
Mar 25, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Jul 6, 2004	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Jun 20, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Written Request

Products

4 strengths and forms


ReyatazEQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Atazanavir Sulfate	DiscontinuedReference drug
ReyatazEQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Atazanavir Sulfate	DiscontinuedReference drug
ReyatazEQ 200MG BASE · capsule;oral	Atazanavir Sulfate	RxReference drug
ReyatazEQ 300MG BASE · capsule;oral	Atazanavir Sulfate	RxReference drug

All 38 submissions, including labeling and manufacturing supplements


Dec 5, 2024	Supplement 49Labeling · Standard review	Approved	Label Letter
Nov 7, 2023	Supplement 48Labeling · Standard review	Approved	Label Letter
Apr 14, 2023	Supplement 47Manufacturing	Approved	Letter
Sep 24, 2020	Supplement 44Labeling · Standard review	Approved	Letter Label
Apr 18, 2018	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 20, 2017	Supplement 41Labeling · Standard review	Approved	Label Letter
May 23, 2017	Supplement 40Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 39Labeling	Approved	Letter Label
Sep 24, 2015	Supplement 38Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Reissue Amendment 6 Pediatric Reissue Amendment 5
Mar 27, 2015	Supplement 37Labeling	Approved	Label Letter
Feb 26, 2015	Supplement 36Labeling	Approved	Letter
Jun 2, 2014	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Label Letter
Feb 26, 2014	Supplement 34Manufacturing · Priority review	Approved	None posted
Aug 15, 2013	Supplement 33Labeling · Standard review	Approved	Label Letter
Aug 15, 2013	Supplement 32Labeling · Standard review	Approved	Label Letter
Jan 30, 2013	Supplement 31Labeling · Standard review	Approved	Letter
Mar 14, 2012	Supplement 28Labeling · Standard review	Approved	Label Letter
Feb 17, 2012	Supplement 27Labeling	Approved	Label Letter
Oct 17, 2011	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 4, 2011	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 26, 2010	Supplement 23Labeling	Approved	Label Letter
Jan 22, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 5, 2009	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 30, 2008	Supplement 17Efficacy (new indication or use)	Approved	Label Letter
Aug 15, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 25, 2008	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Feb 20, 2008	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 21, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 22, 2007	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 16, 2006	Supplement 9Manufacturing	Approved	Letter Label
Aug 9, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 9, 2006	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 25, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 18, 2005	Supplement 5Labeling · Standard review	Approved	Label Letter
Oct 5, 2004	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 6, 2004	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Mar 16, 2004	Supplement 1Labeling · Standard review	Approved	Label Letter
Jun 20, 2003	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 21567
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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