Caplin Steriles Ltd has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Sumatriptan injection USP, 6 mg/0.5 mL (12 mg/mL) single-dose vials, Caplin Point Laboratories said in a regulatory filing.
The product is a generic version of Imitrex injection of GlaxoSmithKline, USA, it added.
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache, the filing said.
Shares of Caplin Point Laboratories were trading at Rs 690.45 per scrip on BSE, up 0.14 per cent from its previous close. PTI AKT SHW