Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) covering Sumatriptan injection — in strengths of 4 mg/0.5 mL and 6 mg/0.5 mL — delivered via a single-dose autoinjector system. The approved product is therapeutically equivalent to the reference-listed drug, Imitrex STATdose System, priorly marketed by GlaxoSmithKline.

According to industry data, the US market for the therapy is estimated at approximately USD 73 million for the twelve-month period ending September 2025. The indication covers the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache in adults.

This approval also marks Alembic’s first approved drug-device combination product, positioning the company to expand its presence in the US complex generics market.