Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, single-dose autoinjector system.
The approved product 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:
With this approval, Alembic’s cumulative ANDA count now stands at 228 approvals, including 207 final and 21 tentative approvals, from the USFDA.
Founded in 1907, Alembic Pharmaceuticals Limited is a vertically integrated research-driven pharmaceutical company engaged in manufacturing and marketing a wide range of generic pharmaceutical products across global markets. The company’s state-of-the-art facilities are approved by leading regulatory authorities, including the USFDA, reflecting its ongoing commitment to quality and innovation in healthcare.
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