Chennai, July 14, 2021: Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sumatriptan Injection USP, 6 mg/0.5 mL (12 mg/mL) Single dose Vials, a generic therapeutic equivalent version of (RLD), IMITREX Injection, of GlaxoSmithKline, USA.
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache. According to IQVIA TM (IMS Health), Sumatriptan Injection had US sales data of approximately $5 million for the 12-month period ending March 2021, for Vial presentation.