Caplin Sterlies receives USFDA final approval for Sumatriptan Injection

Caplin Point Laboratories announced that its subsidiary, Caplin Sterlies, 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 IQVIATM (IMS Health), Sumatriptan Injection had US sales data of approximately $5 million for the 12-month period ending March 2021, for Vial presentation.

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