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.