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Mylan Unit Gets FDA Approval For First Generic Version Of Lescol Capsules

Mylan Inc.'s (MYL) subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or ANDA for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.

According to a settlement and license deal with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012. Lescol Capsules had U.S. sales of nearly $27.9 million for the year ending December 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.

by RTTNews Staff Writer

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