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 Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). This product is manufactured in Mylan's Morgantown, West Virginia facility.
Mylan chairman and CEO Robert J Coury said, "This particular approval is especially important at this time on top of the many other approvals supporting our Morgantown facility and its exemplary 48-year track record of delivering high quality products to our customers and patients from one of the largest pharmaceutical manufacturing plants in the world. I would like to again thank all of Mylan's hardworking employees for their continued dedication to product quality and safety."
Mylan's Sumatriptan Succinate Tablets are the generic version of GlaxoSmithKline's migraine treatment Imitrex. This product had total US sales of approximately $934 million for the 12 months ending June 30 for the same strengths, according to IMS Health. Mylan is shipping immediately.
Currently, Mylan has 120 ANDAs pending FDA approval representing $85.6 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.3 billion in annual brand sales, according to IMS Health.