Back grey_arrow_rt.gif
Teva Announces Tentative FDA Approval of Ribavirin Tablets
  Press announcement from Teva
Jerusalem, Israel, September 18, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Ribavirin Tablets, 200 mg. Final approval is expected upon expiry of brand exclusivity in December 2005.
Upon final approval, Teva's Ribavirin Tablets will be the AB-rated generic equivalent of Roche's CopegusŪ Tablets, a product indicated for use in combination with peginterferon alfa-2a for treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
The brand product has annual sales of approximately $206 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.
  icon paper stack View Older Articles   Back to Top