Treats chronic hepatitis B virus infection. NDA 21798, held by Bristol Myers Squibb. Entecavir.
As of Nov 15, 2026, NDA 21798 (Baraclude), held by Bristol Myers Squibb, was first approved by FDA on Mar 29, 2005, with 18 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 19Efficacy (new indication or use) · Priority review | Approved | |
| Oct 12, 2012 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2010 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2009 | Supplement 8Efficacy (new indication or use) | Approved | |
| Jul 25, 2008 | Supplement 6Efficacy (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 dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Baraclude0.05MG/ML · solution;oral | Entecavir | RxReference drug |
| Aug 18, 2026 | Supplement 25Labeling · Standard review | Approved | |
| Nov 6, 2019 | Supplement 24Labeling · Standard review | Approved | |
| Dec 20, 2018 | Supplement 23Labeling · Standard review | Approved | |
| Jun 22, 2018 | Supplement 21Labeling · Standard review | Approved | |
| Mar 20, 2014 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Dec 19, 2013 | Supplement 18Labeling · Standard review | Approved | |
| Jun 18, 2013 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Oct 12, 2012 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 2010 | Supplement 12Labeling · Standard review | Approved | |
| Oct 15, 2010 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2009 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 25, 2009 | Supplement 10Labeling · Standard review | Approved | |
| Jul 25, 2008 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2008 | Supplement 7Labeling · 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 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
