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Corporate - Regulatory Bodies & Rulings
Aurobindo drug gets US FDA nod

Hyderabad, Feb. 1

Aurobindo Pharma Ltd has received tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market Sumatriptan Succinate tablets in 25mg, 50mg and 100mg. The approval was 63rd Abbreviated New Drug Approval (ANDA) approval for the Hyderabad-based company. Sumatriptan Succinate tablets are the generic equivalent of GlaxoSmithKline’s Imitrex tablets, which are indicated for the treatment of acute migraine headache. The annual sales of Suma triptan Succinate tablets in the US were approximately $950 million in the last fiscal year, the release added.

— Our Bureau

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