Unichem Lab receives USFDA approval to market generic anticonvulsant drug

Unichem Laboratories Ltd on Tuesday said it has received approval from the US health regulator to market its generic carbamazepine tablets, indicated as an anticonvulsant drug. The approval granted by the US Food and Drug Administration USFDA is for the abbreviated new drug application ANDA of Carbamazepine Tablets of strength 200 mg, Unichem said in a regulatory filing.

Unichem Laboratories Ltd on Tuesday said it has received approval from the US health regulator to market its generic carbamazepine tablets, indicated as an anticonvulsant drug. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Carbamazepine Tablets of strength 200 mg, Unichem said in a regulatory filing. It is the generic version of Tegretol (Carbamazepine) tablet, 200 mg of Novartis Pharmaceuticals Corp.

The drug will be commercialised from the company's Goa plant, it added.

Carbamazepine tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia, a condition that causes painful sensations on one side of the face.