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news.Barr Pharmaceuticals has announced that its subsidiary, Barr Laboratories, has received tentative approval from the FDA for its generic version of Boehringer Ingelheim Pharmaceuticals's Mirapex tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg.
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Mirapex (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
The company believes that it is the first to file an abbreviated new drug application (ANDA) with a paragraph IV certification for Mirapex.
A tentative approval reflects FDA’s preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.