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news.Barr Laboratories has received final approval from the FDA for pramipexole dihydrochloride 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
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The company’s pramipexole dihydrochloride is a generic version to Boehringer Ingelheim’s Mirapex tablets.
The company is currently challenging a patent protecting Mirapex and a trial is scheduled to begin on March 10, 2008 in the District Court in Delaware. Under the terms of a Court Order, Barr has agreed not to launch its pramipexole dihydrochloride tablets product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.