Mylan gets nod for additional strengths of generic Mirapex

PITTSBURGH The Food and Drug Administration has approved a Mylan generic drug for Parkinson’s disease, Mylan said Thursday.

 

The drug maker announced the approval of pramipexole dihydrochloride tablets in the 0.125-mg, 0.25-mg, 0.5-mg, 1-mg and 1.5-mg strengths. The drug is a generic version of Boehringer Ingelheim’s Mirapex.

 

 

Various versions of the drug had sales of $536 million during the 12-month period ended in June, according to IMS Health. Mylan has had approval of a 0.75-mg formulation of the drug since April, and plans to immediately begin shipping the newly approved strengths.