Teva Pharmaceutical (TEVA) Receives Tentative FDA Approval for Generic Gemzar
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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eli Lilly and Co's (NYSE: LLY) cancer treatment Gemzar (Gemcitabine) for injection, 200 mg base/vial.
Teva is currently in patent litigation concerning this product in the U.S. District Court for the Southern District of Indiana. A suit was brought against Teva in February 2006 involving Teva's paragraph IV certification to U.S. Patent Nos. 4,808,614 and 5,464,826.
Final approval is expected upon the earlier of a favorable decision in the case or expiry of the mandatory stay of approval in July 2008.
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