Alembic Pharmaceuticals receives USFDA approval for Sumatriptan single-dose autoinjector
The product marks Alembic’s first drug–device combination to be approved in the United States
Alembic Pharmaceuticals announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, in a single-dose autoinjector system.
The approved ANDA is therapeutically equivalent to the reference listed drug, Imitrex STATdose System (4 mg/0.5 mL and 6 mg/0.5 mL), of GlaxoSmithKline Intellectual Property Ltd., England. According to the company, sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura, and for the acute treatment of cluster headache. The company advised referring to the product label for detailed indications.
This approval represents Alembic’s first drug–device combination product. Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, single-dose autoinjector system has an estimated market size of US$ 73 million for the twelve months ending September 2025, based on IQVIA data.
Alembic stated that it now has a cumulative total of 228 ANDA approvals from the USFDA, including 207 final approvals and 21 tentative approvals.