Last Updated : Tuesday, May 19, 2020 14:08:31

JB CHEM & PHARMA gets USFDA nod to sell medicine to treat epilepsy

MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered Indian pharmaceutical products manufacturing company JB Chemicals & Pharmaceuticals Ltd said of having got USFDA (US Food and Drugs Administration) approval for the company’s abbreviated new drug application for treatment of epilepsy, according to which the company is now entitled to sell the same product.

In a regulatory filing with subject-line titled, “ANDA approval by US FDA”, it further read that, this is to inform that US FDA has approved Company’s Abbreviated New Drug Application (ANDA) for Carbamazepine Extended Release Tablets USP 100 mg, 200 mg and 400 mg. (for treatment of Epilepsy and Trigeminal Neuralgia).

The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp. According to IQVIA, US sales were approximately USD 128 million.

The Company plans to commercialize this product in Q3 of this financial year and is expected to boost the Company’s US sales.

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