Mylan Pharmaceuticals Inc., a subsidiary of Mylan Inc., the leading generic and specialty pharmaceutical company, has received final approval from the US 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 US Patent No. 5,356,896, which expires on June 12.
Lescol capsules had US 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.