Published on July 10, 2007 at 12:50 PM
Barr Pharmaceuticals, Inc. has announced that its subsidiary Barr Laboratories, Inc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Pharmacia and Upjohn Company's Dostinex (cabergoline) tablets, 0.5 mg.
The Company's Abbreviated New Drug Application (ANDA) was acquired from Teva Pharmaceuticals Industries Ltd. in connection with the acquisition of Ivax by Teva in January 2006. The Company plans to launch a product that is supplied by Teva in September 2007.
Dostinex had annual sales of approximately $68 million for the twelve months ended May 2007, based on IMS sales data.
Cabergoline tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
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