Mylan receives US FDA approval for generic Adalat CC tablets
Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US 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 US 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
Dec 14, 2010