Pharmaceutical company Aurobindo Pharma Ltd has received a tentative approval from the US Food and Drug Administration for its Sumatriptan Succinate tablets, used in the treatment of acute migraine headaches.
The Hyderabad-based company has received the go-ahead for manufacturing and marketing 25 mg, 50 mg and 100 mg Sumatriptan tablets in the US, the company said in a statement to the Bombay Stock Exchange.
The tablets by the company are generic equivalents of GlaxoSmithKline’s Imitrex tablets widely prescribed in the US.
It is used specifically for treating nerves and blood vessels that are believed to trigger total migraine.
This is the 63rd abbreviated new drug application (ANDA) approval that the company has received from the US FDA.
The annual sales of the Sumatriptan succinate tablets in the US were around 950 million dollars last year, according to data from international consulting and data services company IMS Health.
Shares of the company were trading at Rs 300, up 1.9 per cent on the BSE.