Mylan receives final FDA approval for generic Lescol Capsules ANDA

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (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.

Pursuant to a settlement and license agreement 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 approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.

Currently, Mylan has 172 ANDAs pending FDA approval representing $100.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

SOURCE Mylan Inc.