FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Sep 30 2009

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

Carbidopa and Levodopa Tablets are the generic version of Bristol Myers Squibb's Parkinson's treatment Sinemet®, 10mg/100mg, 25mg/100mg and 25mg/250 mg. For the 12 months ending June 30, 2009, Carbidopa and Levodopa tablets had U.S. sales of approximately $79 million for the same strengths, according to IMS Health. Mylan has launched this product.

Currently, Mylan has 123 ANDAs pending FDA approval representing $86.1 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $17.4 billion in annual brand sales, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.