Aurobindo Pharma gets FDA tentative nod for generic version of GSK migraine drug
Aurobindo Pharma Ltd has received tentative approval from the US Food and Drug Administration to manufacture and sell Sumatriptan Succinate Tablets, a generic version of GlaxoSmithKline's Imitrex, which is used to treat acute migraine headaches.
The tentative approval refers to the patent expiry issues and that Aurobindo expects to sell the generic Sumatriptan tablets from Jan 2009. The first patent for Sumatriptan expired on June 28, 2007, but there have been several lawsuits and settlements between GSK and several generic drug makers over Sumatriptan.
Annual sales of Sumatriptan Succinate Tablets in the US to end-March 2007, were 950 million USD (IMS Health).