Treats human immunodeficiency virus (HIV-1) infection. NDA 20978, held by Viiv Hlthcare. Abacavir Sulfate.
As of Nov 14, 2026, NDA 20978 (Ziagen), held by Viiv Hlthcare, was first approved by FDA on Dec 17, 1998, with 30 approved supplements and 0 published complete response letters.
ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
| Mar 23, 2015 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2008 | Supplement 20Efficacy (new indication or use) | Approved | |
| Aug 2, 2004 | Supplement 14Efficacy (new indication or use) | Approved | |
| Apr 15, 2004 | Supplement 13Efficacy (new indication or use) | Approved | |
| Dec 15, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZiagenEQ 20MG BASE/ML · solution;oral | Abacavir Sulfate | RxReference drug |
| Nov 24, 2020 | Supplement 38Labeling · Standard review | Approved | |
| May 9, 2018 | Supplement 37Labeling · Standard review | Approved | |
| May 9, 2018 | Supplement 36Labeling · Standard review | Approved | |
| Mar 20, 2017 | Supplement 35Labeling · Standard review | Approved | |
| Sep 30, 2015 | Supplement 34Labeling · Standard review | Approved | |
| Mar 23, 2015 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Feb 19, 2015 | Supplement 32Labeling · Standard review | Approved | |
| Sep 11, 2013 | Supplement 30Labeling · Standard review | Approved | |
| May 18, 2012 | Supplement 29Labeling · Standard review | Approved | |
| Mar 15, 2012 | Supplement 28Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 27Labeling | Approved | |
| May 13, 2011 | Supplement 26REMS | Approved | |
| Aug 4, 2010 | Supplement 24REMS | Approved | |
| Dec 19, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Jul 18, 2008 | Supplement 20Efficacy (new indication or use) | Approved | |
| May 7, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Aug 11, 2006 | Supplement 16Labeling · Standard review | Approved | |
| Aug 2, 2004 | Supplement 14Efficacy (new indication or use) | Approved | |
| Jul 26, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Apr 15, 2004 | Supplement 13Efficacy (new indication or use) | Approved | |
| Jul 17, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Dec 24, 2002 | Supplement 9Manufacturing · Priority review | Approved | |
| Oct 2, 2002 | Supplement 8Labeling · Standard review | Approved | |
| Aug 14, 2002 | Supplement 10Labeling · Standard review | Approved | |
| Jun 4, 2002 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 28, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Jul 13, 2001 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Dec 15, 2000 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 17, 1998 | 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
