Treats human immunodeficiency virus type 1 (HIV‑1) infection. NDA 20596, held by Viiv Hlthcare. Lamivudine.
As of Nov 13, 2026, NDA 20596 (Epivir), held by Viiv Hlthcare, was first approved by FDA on Nov 17, 1995, with 32 approved supplements and 0 published complete response letters.
EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2016 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2015 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Jun 24, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 1999 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Apr 11, 1997 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 17, 1995 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epivir10MG/ML · solution;oral | Lamivudine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2019 | Supplement 38Labeling · Standard review | Approved | |
| Apr 27, 2018 | Supplement 37Labeling · Standard review | Approved | |
| Sep 25, 2017 | Supplement 36Labeling · Standard review | Approved | |
| Jul 20, 2016 | Supplement 35Efficacy (new indication or use) · Priority review | Approved | |
| Sep 30, 2015 | Supplement 34Labeling · Standard review | Approved | |
| Mar 23, 2015 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Feb 19, 2015 | Supplement 33Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 30Labeling | Approved | |
| Oct 25, 2006 | Supplement 27Labeling · Standard review | Approved | |
| Jun 13, 2006 | Supplement 25Labeling · Standard review | Approved | |
| Nov 22, 2004 | Supplement 21Labeling · Standard review | Approved | |
| Sep 29, 2004 | Supplement 22Labeling · Standard review | Approved | |
| Nov 13, 2003 | Supplement 20Labeling · Standard review | Approved | |
| Dec 24, 2002 | Supplement 19Manufacturing | Approved | |
| Oct 8, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Sep 13, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Jun 24, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2002 | Supplement 17Labeling · Standard review | Approved | |
| Jun 19, 2001 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 6, 2001 | Supplement 13Labeling · Standard review | Approved | |
| Jan 5, 2001 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 18, 1999 | Supplement 10Manufacturing | Approved | |
| Oct 8, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 8, 1999 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 8, 1999 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 3, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Dec 15, 1997 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 15, 1997 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 13, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Apr 11, 1997 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jul 31, 1996 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 17, 1995 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
