Alembic Pharmaceuticals has received USFDA final approval for Sumatriptan Injection USP, specifically the 4 mg/0.5 mL and 6 mg/0.5 mL single-dose autoinjector system. This approval is therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System. The injection is indicated for the acute treatment of migraines and cluster headaches in adults, marking Alembic’s entry into drug-device combination products.
USFDA Approval for Sumatriptan Injection
Alembic Pharmaceuticals Limited announced it has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Injection USP, in both 4 mg/0.5 mL and 6 mg/0.5 mL dosages, presented as a single-dose autoinjector system.
Therapeutic Equivalence
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, marketed by GlaxoSmithKline Intellectual Property Ltd. England. This approval allows Alembic to market a generic version of this important medication.
Indications and Use
Sumatriptan injection is indicated for use in adults for two primary conditions:
- The acute treatment of migraine, with or without aura.
- The acute treatment of cluster headache.
Alembic encourages healthcare professionals to refer to the product label for detailed indications and usage guidelines.
First Drug-Device Combination Product
This approval represents Alembic’s initial foray into drug-device combination products, diversifying its portfolio and leveraging its manufacturing capabilities.
Market Size
Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System, has an estimated market size of US$ 73 million for the twelve months ending September 2025, according to IQVIA data.
ANDA Approvals
With this approval, Alembic Pharmaceuticals now holds a cumulative total of 228 ANDA approvals from the USFDA, comprising 207 final approvals and 21 tentative approvals.
Source: BSE
