Alembic Pharma Gets US FDA Nod For Carbamazepine Tablets

Alembic Pharmaceuticals on Thursday announced that it has received the final approval from the US Food and Drug Administration for its abbreviated new drug application for Carbamazepine tablets in the 200 mg strength, the company said in an exchange filing.

Carbamazepine is used as an anticonvulsant and to treat trigeminal neuralgia. Alembic’s version is therapeutically equivalent to Tegretol tablets, the reference listed drug developed by Novartis Pharmaceuticals.

The approved product had an estimated market size of $32 million for the 12 months ended December, the company said.