Teva's Granisetron HCl Injection products are the generic equivalents of Hoffman-La Roche's Kytril.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration has granted tentative approval for its ANDAs (abbreviated new drug application) for Granisetron HCl Injection, 1 mg/mL single dose vials and Granisetron HCl Injection, 4 mg/4mL in multi-dose vials.
Teva said that final approval of these products was 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.
According to Teva, total annual U.S. sales of the brand product, in both configurations, are approximately $140 million for all indications.
Published by Globes [online], Israel business news - www.globes.co.il - on August 18, 2005