India, Nov. 10 -- Alembic Pharmaceuticals Ltd announced that it has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Sumatriptan Injection, used in the treatment of migraine.
The approval covers the company's Abbreviated New Drug Application (ANDA) for Sumatriptan Injection in strengths of 4 mg/0.5 ml and 6 mg/0.5 ml single-dose autoinjector systems, the company said in a regulatory filing.
Notably, this marks Alembic's first drug–device combination product, expanding its portfolio in the neurology and injectable segments.
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