Alembic Pharmaceuticals secures USFDA approval for carbamazepine tablets

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to Novartis Pharmaceuticals Corporation's Tegretol Tablets, 200 mg. Carbamazepine Tablets USP, 200 mg are indicated for use as an anticonvulsant drug, and for the treatment of pain associated with true trigeminal neuralgia. The market size for Carbamazepine Tablets USP, 200 mg is estimated at USD 32 million for the twelve months ending December 2024. Alembic now holds a cumulative total of 222 ANDA approvals, including 196 final and 26 tentative approvals, from the USFDA.