FDA approves Mylan's generic Adalat CC Tablets 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 Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Bayer's Adalat® CC Tablets, a treatment for hypertension.
Nifedipine Tablets had U.S. sales of approximately $82 million for the 12 months ending June 30, 2010, according to IMS Health.
Currently, Mylan has 161 ANDAs pending FDA approval representing $98.8 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.