Mylan Receives FDA Approval For Carbidopa, Levodopa

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.