Treats chronic hepatitis B virus infection. NDA 21797, held by Bristol Myers Squibb. Entecavir.
As of Nov 14, 2026, NDA 21797 (Baraclude), held by Bristol Myers Squibb, was first approved by FDA on Mar 29, 2005, with 19 approved supplements and 0 published complete response letters.
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
| Mar 20, 2014 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Oct 12, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2012 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2010 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2009 | Supplement 8Efficacy (new indication or use) | Approved | |
| Jul 25, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 2007 | Supplement 2Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Supplement 1Efficacy (new indication or use) | Approved | |
| Mar 29, 2005 | Original applicationNew molecular entity · Priority review | Approved |
| Aug 18, 2026 | Supplement 27Labeling · Standard review | Approved | |
| Nov 6, 2019 | Supplement 23Labeling · Standard review | Approved | |
| Dec 20, 2018 | Supplement 21Labeling · Standard review | Approved | |
| Jun 22, 2018 | Supplement 19Labeling · Standard review | Approved | |
| Mar 20, 2014 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Dec 19, 2013 | Supplement 17Labeling · Standard review | Approved | |
| Jun 18, 2013 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Apr 16, 2013 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Oct 12, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2012 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 2010 | Supplement 11Labeling | Approved | |
| Oct 15, 2010 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2009 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 25, 2009 | Supplement 9Labeling · Standard review | Approved | |
| Jul 25, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Jul 24, 2007 | Supplement 3Labeling · Standard review | Approved | |
| Mar 27, 2007 | Supplement 2Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Supplement 1Efficacy (new indication or use) | Approved | |
| Mar 29, 2005 | Original applicationNew molecular entity · 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
