Treats HIV-1 infection. NDA 206352, held by Bristol Myers Squibb. Atazanavir Sulfate.
As of Nov 13, 2026, NDA 206352 (Reyataz), held by Bristol Myers Squibb, was first approved by FDA on Jun 2, 2014, with 9 approved supplements and 0 published complete response letters.
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:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2015 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jun 2, 2014 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ReyatazEQ 50MG BASE/PACKET · powder;oral | Atazanavir Sulfate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 5, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Nov 7, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Sep 24, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Apr 18, 2018 | Supplement 7Labeling · Standard review | Approved | |
| Oct 20, 2017 | Supplement 6Labeling · Standard review | Approved | |
| May 23, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2016 | Supplement 4Labeling | Approved | |
| Sep 24, 2015 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2015 | Supplement 2Labeling | Approved | |
| Jun 2, 2014 | Original applicationNew dosage form · Priority review | Approved |
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
