Skip to main content

Baraclude FDA Approval History

FDA Approved: Yes (First approved March 29, 2005)
Brand name: Baraclude
Generic name: entecavir
Dosage form: Tablets / Oral Solution
Company: Bristol-Myers Squibb Company
Treatment for: Hepatitis B

Baraclude (entecavir) is a nucleoside analogue oral antiviral therapy for the treatment of chronic hepatitis B in adults.

Development timeline for Baraclude

DateArticle
Oct 18, 2010Approval U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
Mar 29, 2005Approval Baraclude Bristol-Myers Squibb Company - Treatment for Chronic Hepatitis B
Mar 11, 2005Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Baraclude (entecavir), an Investigational Oral Antiviral Agent for Chronic Hepatitis B
Oct  4, 2004Bristol-Myers Squibb Submits Applications in U.S. and Europe to Market Entecavir, an Investigational Antiviral Treatment For Chronic Hepatitis B Infection

See also

Baraclude (entecavir) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer