Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc has received approval from the US 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 US 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 ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories.