Aurobindo Pharma Ltd has received tentative approval from the US Food & Drug Administration to manufacture and market sumatriptan succinate tablets 25mg, 50mg and 100mg.

Sumatriptan succinate tablets are the generic equivalent of GlaxoSmithKline's Imitrex tablets, which are indicated for the treatment of acute migraine headaches.

Annual sales of sumatriptan succinate tablets 25mg, 50mg and 100mg, in the US were approximately US$ 950 million for the twelve months ending MAT/3/2007 according to IMS Health data.

According to a company press release, this is Aurobindo's 63rd ANDA approval from the US FDA.