September 22, 2008
Mylan Receives FDA Approval for Generic Version of Parkinson’s Treatment Parcopa(R) ODT
PITTSBURGH, Sept. 22 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. 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(R) ODT. This product had annual U.S. 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. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit http://www.mylan.com/.
CONTACT: Michael Laffin (Media) or Dan Crookshank (Investors), both ofMylan Inc., +1-724-514-1813
Web site: http://www.mylan.com/