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 Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex® Tablets, a Parkinson's disease treatment.
Pramipexole Dihydrochloride Tablets had U.S. sales of approximately $536 million for the 12 months ending June 30, 2010, according to IMS Health. Mylan Pharmaceuticals received final FDA approval for the 0.75 mg strength of Pramipexole Dihydrochloride Tablets on April 9, 2010. All strengths of the product are available for immediate shipment.
Currently, Mylan has 153 ANDAs pending FDA approval representing $95 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.