Pharmaceutical Business review

Mylan wins FDA approval for Parkinson’s drug

Carbidopa and Levodopa orally disintegrating tablets (ODT), indicated for the treatment of idiopathic Parkinson’s disease, are the generic version of Schwarz Pharma’s Parcopa ODT.

This product, which Mylan has already started to ship, will be the first generic version of Parcopa to reach the market. Currently, Mylan has 110 abbreviated new drug applications pending FDA approval, 23 of which are potential first-to-file opportunities.