Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the FDA for its AbbreviatedNew 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 MyersSquibb’s Parkinson’s treatment Sinemet, 10mg/100mg, 25mg/100mg and 25mg/250mg. For the 12 months ending June 30, 2009, Carbidopa and Levodopa tablets hadU.S. sales of approximately $79 million for the same strengths, according toIMS Health. Mylan has launched this product. Currently, Mylan has 123 ANDAs pending FDA approval representing $86.1billion in annual brand sales, according to IMS Health. Thirty-five of thesepending ANDAs are potential first-to-file opportunities, representing $17.4billion in annual brand sales, according to IMS Health.
