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28/07/2025 12:55

Alembic Pharma gets USFDA approval for Generic Carbamazepine Tablets

Alembic Pharmaceuticals announced on Monday that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Carbamazepine extended-release tablets. The medication is indicated for the treatment of seizures and relief of nerve pain.

The approval pertains to the company’s Abbreviated New Drug Application (ANDA) for Carbamazepine extended-release tablets in strengths of 100 mg, 200 mg, and 400 mg.

According to the company’s statement, the approved product is therapeutically equivalent to Tegretol-XR, the reference listed drug marketed by Novartis Pharmaceuticals Corporation, in the same dosage strengths.