Mylan Obtains FDA Approval For Sumatriptan Succinate Tablets

Mylan has received FDA approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25mg, 50mg and 100mg.

Mylan’s Sumatriptan Succinate Tablets are the generic version of GlaxoSmithKline’s migraine treatment Imitrex. Mylan plans for shipping soon.

Currently, Mylan has 120 ANDAs pending FDA approval representing $85.6 billion in annual brand sales. Over 34 of these pending ANDAs are potential first-to-file opportunities, representing $17.3 billion in annual brand sales, according to IMS Health.

Robert Coury, chairman and CEO of Mylan, 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. I would like to again thank all of Mylan’s hardworking employees for their continued dedication to product quality and safety.