Alembic Pharmaceuticals gets USFDA nod for generic migraine treatment injection

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Sumatriptan injection used in treatment of migraine.

The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) Sumatriptan Injection of strengths 4 mg/0.5 ml and 6 mg/0.5 ml single-dose autoinjector system, Alembic Pharmaceuticals said in a regulatory filing.

This is Alembic's first drug device combination product, it added.


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, the company said.

Sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura; and also for the acute treatment of cluster headache, it added.