September 23, 2008
Mylan Wins FDA Approval for Parkinson’s Drug
Mylan Inc has announced that its subsidiary Mylan Pharmaceuticals Inc has received final approval from the FDA for its abbreviated new drug application for Carbidopa and Levodopa orally disintegrating tablets, 10mg/100mg, 25mg/100mg and 25mg/250mg.
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.