Mylan Wins FDA Approval for Generic Risperdal Tablets
September 17, 2008
Mylan Inc has announced that its subsidiary Mylan Pharmaceuticals Inc has received final approval from the FDA for its abbreviated new drug application for risperidone tablets USP, 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg.
Risperidone tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen’s Risperdal tablets. Mylan will ship the product shortly.
Currently, the company has 109 abbreviated new drug applications pending FDA approval, 22 of which are potential first-to-file opportunities.