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|August 18, 2005 11:41 a.m.|
|Teva Announces Tentative Approval of Granisetron Hydrochloride Injection|
|Jerusalem, Israel, August 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 ANDAs for Granisetron HCl Injection, 1 mg/mL single dose vials and Granisetron HCl Injection, 4 mg/4mL in multi-dose vials. Final approval of these products is anticipated subsequent to the expiry of patent protection in December 2007. |
Teva's Granisetron HCl Injection products are the generic equivalents of Hoffman-La Roche's antinauseant and antiemetic agent Kytril® Injection.
Total annual U.S. sales of the brand product, in both configurations, are approximately $140 million for all indications.
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.