Alembic Pharmaceuticals gets USFDA nod for migraine autoinjector

Alembic Pharmaceuticals Limited announced on November 7, 2025, that it has received final approval from the US Food & 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, Single-Dose Autoinjector System. This marks Alembic's first drug-device combination product, which is therapeutically equivalent to GlaxoSmithKline's Imitrex STATdose System.

The Sumatriptan injection is indicated for the acute treatment of migraine, with or without aura, and cluster headaches in adults. The estimated market size for these products is $73 million for the twelve months ending September 2025, according to IQVIA data.

This approval contributes to Alembic's cumulative total of 228 ANDA approvals from the USFDA, comprising 207 final approvals and 21 tentative approvals. Alembic Pharmaceuticals is a vertically integrated pharmaceutical company headquartered in India, with USFDA-approved research and manufacturing facilities.