Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa orally disintegrating tablets (ODT), 10 mg/100 mg, 25 mg/100 mg and 25 mg/250 mg.
Carbidopa and Levodopa ODT, indicated for the treatment of idiopathic Parkinson's disease, are the generic version of Schwarz Pharma's Parcopa ODT. This product had annual US sales of approximately $7.4 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
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 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Mylan Inc., which provides products to customers in more than 120 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world.