Mylan has announced that its subsidiary Mylan Pharmaceuticals has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250mg.
Carbidopa and Levodopa tablets are the generic version of Bristol Myers Squibb’s Parkinson’s treatment Sinemet, 10mg/100mg, 25mg/100mg and 25mg/250mg.
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.