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Tyzeka Approval History

  • FDA approved: Yes (First approved October 25th, 2006)
  • Brand name: Tyzeka
  • Generic name: telbivudine
  • Dosage form: Tablets
  • Company: Novartis
  • Treatment for: Hepatitis B

Tyzeka (telbivudine) is a synthetic thymidine nucleoside analogue indicated for the treatment of chronic hepatitis B.

Development History and FDA Approval Process for Tyzeka

DateArticle
Oct 25, 2006Approval Tyzeka Novartis - Treatment for Chronic Hepatitis B
Jan  3, 2006Idenix and Novartis Announce New Drug Application Submitted to the U.S. Food and Drug Administration for Telbivudine for the Treatment of Chronic Hepatitis B

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