Alembic Pharma Gains USFDA Nod for Generic Sumatriptan Injection

Alembic Pharmaceuticals received USFDA approval for its Sumatriptan injection, a generic equivalent for treating migraines and cluster headaches. This marks Alembic's first drug device combination. The approval covers 4 mg/0.5 ml and 6 mg/0.5 ml single-dose autoinjector systems, equivalent to GlaxoSmithKline's Imitrex STATdose.

Alembic Pharmaceuticals Ltd has achieved a significant milestone with the United States Food & Drug Administration's approval for their generic version of Sumatriptan injection, used in combating migraines.

The clearance pertains to their Abbreviated New Drug Application for Sumatriptan Injection in doses of 4 mg/0.5 ml and 6 mg/0.5 ml, both administered via a single-dose autoinjector system.

This approval is notably Alembic's inaugural drug-device combination product, establishing it as a therapeutic equivalent to GlaxoSmithKline's Imitrex STATdose System.

(With inputs from agencies.)