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FDA approves Mylan Pramipexole Dihydrochloride tablets

The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg, the generic version of Boehringer Ingelheim's Mirapex tablets.

Pramipexole Dihydrochloride tablets are used to treat signs and symptoms of Parkinson’s disease and for the treatment of Restless Legs Syndrome (RLS).

Mylan Pharmaceuticals has received final FDA approval for the 0.75 mg strength of Pramipexole Dihydrochloride tablets on 9 April 2010.

All strengths of the product are available for immediate shipment.