Teva Announces Tentative Approval of Generic Gemzar for Injection

Cancer :: Teva Announces Tentative Approval of Generic Gemzar for Injection

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 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.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.




(Cancer :: Teva Announces Tentative Approval of Generic Gemzar for Injection published at SpiritIndia on Monday, May 14, 2007)

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