FDA grants Barr final approval on generic Mirapex

MONTVALE, N.J. Barr Pharmaceuticals has received final approval from the Food and Drug Administration for a generic version of Boehringer Ingelheim Pharmaceuticals Parkinson’s disease Mirapex, according to the Associated Press.

The generic, pramipexole dihydrochloride will be available in 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg.

Before the company can launch the generic, it has to win a patent challenge it filed against Boehringer. The trial is set to begin on March 10, in the District Court in Delaware.

Mirapex had sales of about $324 million for the 12 months that ended in August 2007, according to Barr.

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