Barr Receives Tentative Approval For A Generic Version Of Mirapex(R) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg And 1.5mg
Oct 31st 2007Drug InformationParkinson's Disease
Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.’s Mirapex(R) (Pramipexole Dihydrochloride) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex. [click link for full article]
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