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|July 06, 2005 11:32 a.m.|
|Teva Comments On Fda Letter Regarding Pravastatin Exclusivity|
Jerusalem, Israel, July 6, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received a letter from the U.S. Food and Drug Administration ("FDA") concerning the 180-day exclusivity period applicable to ANDAs for generic Pravastatin Sodium Tablets 10 mg., 20 mg., 40 mg., and 80 mg, the generic equivalents of Pravachol®. The FDA has decided that any 180-day exclusivity period arising from U.S. Patents Nos. 5,030,447, 5,180,589, and 5,622,985 began to run on August 22, 2004, the date the order dismissing a declaratory judgment action suit by Apotex Inc. against Bristol-Myers Squibb Co. became final. This decision is based upon the FDA's interpretation of prior case law.