Caplin Sterlies Receives Final USFDA Approval for Sumatriptan Injection

Caplin Point Laboratories announced that its subsidiary, Caplin Sterlies, has received 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 (RLD), IMITREX Injection, from GlaxoSmithKline, USA.

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 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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First published: Wednesday, July 14, 2021. 1:39 PM IST

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