The FDA last month granted tentative approval to Teva's granisetron HCl injection formulations, the generic equivalents to Hoffman-La Roche's anti-nauseant and anti-emetic agent Kytril. Final approval of these products is anticipated subsequent to the expiry of patent protection in December 2007.
Total annual U.S. sales for the branded product, across two configurations, were approximately $140 million, Teva reported.
In other news, Teva was granted final approval for paroxetine HCl tablets, the generic equivalent to GlaxoSmithKline's antidepressant Paxil. Paxil generated $870 million in 2004 sales, according to IMS Health.
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