J B Chemicals & Pharma gets US FDA nod for hypertension tablets

US FDA approved supplementary ANDA for Atenolol tablets USP 25mg, 50mg and 100 mg

J B Chemicals & Pharmaceuticals has received US health regulator’s nod for Atenolol tablets, used in treatment of high blood pressure. “The United States Food and Drug Administration (US FDA) has approved the company’s supplementary Abbreviated New Drug Application (ANDA) for Atenolol tablets USP 25mg, 50mg and 100 mg,” J B Chemicals & Pharmaceuticals said in a BSE filing. The company, which plans to commercialise this product in the next quarter, said the market for the approved product is about USD 70 million. “The company is focused on US business and this approval will help the company grow its exports,” it added.