US Pharm. 2010;35(12):104.
Mylan Pharmaceuticals Inc. received final approval from the FDA for its 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 in April 2010. All strengths of the product are available for immediate shipment.