Category: Approval/Launch Region: Asia · India Company: Alembic Pharmaceuticals Ltd

Alembic Pharma gets final USFDA approval for Lacosamide tablet Lacosamide tablet

Alembic Pharma gets final USFDA approval for Lacosamide tablet Lacosamide tablet
indicated for the treatment of partial-onset seizures in patients of four years of age and older. izures in patients of four years of age and older. Alembic Pharmaceuticals Ltd gets final approval from the USFDA for its generic version of Lacosamide tablet, indicated for the treatment of partial-onset seizures in patients of four years of age and older. The approval by the US health regulator is for the abbreviated new drug application (ANDA) for Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg, and 200 mg, the company said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Vimpat Tablets -- 50 mg, 100 mg, 150 mg, and 200 mg-of UCB Inc, it

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