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Barr says U.S. tentatively OKs its generic Mirapex

Tue Oct 30, 2007 9:48am EDT

NEW YORK, Oct 30 (Reuters) - Barr Pharmaceuticals Inc BRL.N on Tuesday said U.S. regulators had tentatively approved its generic version of Mirapex, a treatment for Parkinson's disease sold by privately held German drugmaker Boehringer Ingelheim.

Barr said the U.S. Food and Drug Administration has given tentative approval to its tablet forms of the medicine, the chemical name of which is pramipexole, in dosage strengths of 0.125 milligram, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg.

Barr, which sought marketing approval for its generic in May 2005, said the date for a trial in which Boehringer is expected to defend its patent on Mirapex has not yet been set.

In the meantime, Barr said a 30-month stay that prevents the FDA from giving final approval to its generic will expire around Feb. 15, 2008.

Mirapex had sales of about $324 million for the 12 months ended August 2007, Barr said in a release.



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