FDA gives tentative approval to Barr's generic Mirapex

Related Content

No related items were found.

WASHINGTON Barr Laboratories has received tentative approval from the Food and Drug Administration for its generic version of Boehringer Ingelheim Pharmaceuticals’ Mirapex, a drug used for the signs and symptoms of Parkinson’s disease.

Barr filed its abbreviated new drug application for generic Mirapex (pramipexole) 0.25 mg in May 2005. A month later, the company changed the application to include the tablet strengths 0.125, 0.5, 1 and 1.5 mg.

Boehringer Ingelheim filed suit in the U.S. District Court in Delaware Sept. 26, 2005, to prevent Barr from proceeding with commercialization of the product.

Although a trial has been scheduled for Nov. 5, due to a judicial vacancy in the court, the trial is not expected to begin on schedule. A new trial date has not been set.

© 2014 Drug Store News. All Rights Reserved.