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 Pfizer's Procardia XL tablets, a treatment for angina and/or hypertension.
Nifedipine tablets had US sales of approximately $234 million for the 12 months ending March 31, 2010, according to IMS Health.
Currently, Mylan has 137 ANDAs pending FDA approval representing $94.9 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $20.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 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.