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|September 04, 2002 4:19 p.m.|
|Teva Announces Approval of Fenofibrate Capsules (micronized), 67mg. will Have 180 Days of Marketing Exclusivity|
Jerusalem, Israel, September 4, 2002 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted final approval for the company's ANDA for Fenofibrate Capsules (Micronized), 67 mg. The 134 mg and 200 mg strengths were approved April 9, 2002 following a favorable ruling on a motion for summary judgement. Approval of the 67 mg strength was granted upon the expiration of the 30-month clock which resulted from patent litigation. As the first company to file an ANDA with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product. Therefore, this exclusivity period will begin upon Teva's first commercial marketing of the 67 mg strength.