MONTVALE, N.J. -
Generic drug maker Barr Pharmaceuticals Inc. said Tuesday federal regulators granted final marketing approval to its generic version of Boehringer Ingelheim Pharmaceuticals Inc.'s drug Mirapex for Parkinson's disease.
The Food and Drug Administration approved Barr's abbreviated new drug application for pramipexole dihydrochloride (Mirapex) at 0.125, 0.25, 0.5, 1 and 1.5 milligram dosages.
The company believes it is the first to file an abbreviated new drug application with a paragraph IV certification for Mirapex at those dosages. A Paragraph IV certification indicates that a generic drug would infringe an existing patent, but the company claims that the patent is not valid.
The drug is indicated for signs and symptoms of idiopathic Parkinson's disease, which is a degenerative disorder of the central nervous system.
Barr is challenging a patent protecting Mirapex, and a trial is scheduled to begin on March 10, in the District Court in Delaware.
Under terms of a court order, Barr has not yet launched the pramipexole dihydrochloride.
Shares of Barr rose 49 cents to $50.45 in afternoon trading.
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