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Teva Provides Update on Generic Pravachol Exclusivity

Mar 28th 2006

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that United States Court of Appeals for the District of Columbia has vacated the FDA s determination...







that Teva s exclusivity on pravastatin 10, 20, and 40 mg had been triggered and remanded the matter back to the FDA for further decision-making. The FDA has advised the Court that in the event of a remand the FDA would determine that Teva maintains exclusivity on these products and Teva expects final approval with exclusivity in April 2006 when the product patent expires. The Court has also vacated the lower court s prior decision that Teva maintains its exclusivity, so that FDA can provide its reasoning for rejecting the challenge to Teva s exclusivity.

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. Close to 90% of Teva s sales are in North America and Europe.


Teva Pharmaceutical Industries Ltd.

http://www.tevausa.com
Mar 28th 2006


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