Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP
PITTSBURGH, April 21 /PRNewswire-FirstCall/ -- Mylan Inc. NYSE: MYL today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg.
Felodipine Extended-release Tablets USP are the generic version of AstraZeneca Pharmaceutical's Plendil(R) Extended-release tablets, which had U.S. sales of approximately $251 million for the 12 months ending Dec. 31, 2007, according to IMS Health.
This product is shipping immediately.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas