Caplin Steriles Gets USFDA Green Light for Generic Injection for Migraine and Cluster Headache
New Delhi, July 14 (PTI) Pharmaceutical company Caplin Point Laboratories said on Wednesday that its Caplin Steriles arm had received approval from the U.S. health regulator for the generic injection of Sumatriptan used for the acute treatment of migraine and cluster headache.
Caplin Steriles Ltd has obtained 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 single dose vials ( 12 mg / mL), Caplin Point Laboratories stated in a regulatory dossier.
The product is a generic version of the Imitrex injection from GlaxoSmithKline in the United States, he added.
Sumatriptan Injection USP is indicated in adults for the acute treatment of migraine with or without aura, and the acute treatment of cluster headache, according to the record.
Shares of Caplin Point Laboratories were trading at Rs 690.45 per certificate on BSE, up 0.14% from its previous close. PTI AKT SHW
Disclaimer: – This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI