US Approves Generic Version of GSK’s Imitrex Migraine Treatment

10 August 2009 (Last Updated August 10th, 2009 18:30)

Mylan Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for sumatriptan succinate, a generic version of GlaxoSmithKline's migraine treatment Imitrex. The FDA approved an Abbreviated New Drug Application (ANDA) for the generic treatment in 25mg, 50mg and

Mylan Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for sumatriptan succinate, a generic version of GlaxoSmithKline’s migraine treatment Imitrex.

The FDA approved an Abbreviated New Drug Application (ANDA) for the generic treatment in 25mg, 50mg and 100mg amounts.

GlaxoSmithKline’s Imitrex recorded US sales of approximately $934m for the 12 months ending 30 June 2009 for the same strengths.

Mylan chairman and CEO Robert J Coury said that this approval would boost production at the company’s Morgantown facility, which has been developing pharmaceutical products for 48 years.

Mylan has 120 ANDAs pending FDA approval, representing $85.6bn in annual brand sales, according to pharmaceutical intelligence agency IMS Health.