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Baraclude Approval History

  • FDA approved: Yes (First approved March 29th, 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 History and FDA Approval Process for Baraclude

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

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