Alembic Pharmaceuticals Receives USFDA Final Approval for Sumatriptan Injection
Alembic Pharmaceuticals Limited has 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. 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 USS 73 million for twelve months ending September 2025 according to IQVIA.
Key Highlights
- Alembic Pharmaceuticals received USFDA final approval for 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.
- 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 USS 73 million for twelve months ending September 2025 according to IQVIA.