Teva expects to gain exclusivity for cholesterol drug pravastatin in April

By Angela McDaniels

Seattle, March 16 - Teva Pharmaceutical Industries Ltd. said the U.S. Court of Appeals for the District of Columbia has vacated the Food and Drug Administration's determination that Teva's exclusivity on cholesterol-lowering drug pravastatin 10 mg, 20 mg and 40 mg was triggered and remanded the matter back to the FDA for further decision making.

Previously, the FDA advised the court that in the event of a remand, it would determine that Teva maintains exclusivity on these products. Teva, therefore, said it expects to gain final approval of its exclusivity in April when the product patent expires.

The court also vacated the lower court's prior decision that Teva maintains its exclusivity, so that the FDA can provide its reasoning for rejecting the challenge to Teva's exclusivity.

Teva Pharmaceutical is based in Jerusalem, Israel, and develops, manufactures and markets generic pharmaceuticals and active pharmaceutical ingredients.

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