FDA gives tentative approval to Barr's generic Mirapex
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.