Barr gets tentative OK for Parkinson’s drug
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- October
- 30
Barr Pharmaceuticals Inc. reported today that its Pomona-based Barr Laboratories Inc. subsidiary was granted tentative approval from the U.S. Food and Drug Administration for a generic version of a drug to treat symptoms of Parkinson’s disease.
The tentative OK doesn’t allow Barr to begin marketing the drug. Rather, it is a signal by the FDA that Barr’s generic version of Mirapex “satisfies the substantive requirements for approval.�
Barr said it filed an application with the FDA in 2005 to begin selling a generic version of Mirapex tablets, setting in motion a lawsuit brought by the brand-name drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals Inc.
Barr said a trial was scheduled for Nov. 5, but a judicial vacancy leaves the case’s start date in limbo.
Mirapex had annual sales of about $324 million for the year ending August, based on industry sales data, Barr said.
This entry was posted
on Tuesday, October 30th, 2007 at 5:34 pm by David Schepp.
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