Treats human immunodeficiency virus (HIV-1) infection. ANDA 205651, held by Mylan. Nevirapine.
As of Nov 15, 2026, ANDA 205651 (Nevirapine), held by Mylan, was first approved by FDA on Oct 27, 2014, with 5 approved supplements and 0 published complete response letters.
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m 2 or greater. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine400MG · tablet, extended release;oral | Nevirapine | Rx |
| Sep 1, 2026 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 22, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 21, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 27, 2014 | Original application | Approved | None posted |
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
