Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine

Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, 4 mg/0.5 mL and 6 mg/0.5 mL, of GlaxoSmithKline Intellectual Property Ltd. England.

Sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Refer label for a detailed indication. This is 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, have an estimated market size of US$ 73 million for twelve months ending September 2025 according to IQVIA.

Alembic has a cumulative total of 228 ANDA approvals (207 final approvals and 21 tentative approvals) from USFDA.