Mylan Pharmaceuticals Gained Final FDA Approval for Abbreviated New Drug Application

Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product.

The product, a generic version of Novartis' Lescol capsule, is indicated for the treatment of both familial and nonfamilial hypercholesterolemia, mixed dyslipidemia and also for the secondary prevention of cardiovascular disease.

Under an agreement, Novartis granted Mylan a license permitting launch prior to the expiration of the pediatric exclusivity associated with a US Patent, which expires on 12 June 2012.

According to IMS Health, Lescol capsules had US sales of approximately $27.9m for the twelve months ending 31 December 2011.