J B Chemicals and Pharmaceuticals on Monday said it has received approval from the US health regulator to market Carbamazepine extended-release tablets used in the treatment of epilepsy.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Carbamazepine extended-release tablets in strengths of USP 100 mg, 200 mg and 400 mg, J B Chemicals and Pharmaceuticals said in a regulatory filing.
The company's product is indicated for the treatment of epilepsy and trigeminal neuralgia and is the generic version of Novartis Pharmaceuticals' Tegretol XR tablets.
"The company plans to commercialise this product in the third quarter of this financial year and is expected to boost the company's US sales," J B Chemicals and Pharmaceuticals said.
As per IQVIA data, US sales of the product stood at around USD 128 million.