Unichem Laboratories to announce that it has received ANDA approval from United States Food and Drug Administration (USFDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, which are therapeutically equivalent to DIOVANB (Valsartan) tablets, 40 mg, 80 mg, 160 mg and 320 mg of Novartis Pharmaceuticals Corp. Valsartan is a nonpeptide, orally active, and specific angiotensin 11 receptor bloclter acting on the AT1 receptor subtype.
This drug product is indicated for treatment for hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroltes and myocardial infarctions; treatment of heart failure (NYHA class 11-1V); Valsartan tablets significantly reduced Hospitalization for heart failure; reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.
This product will be commercialized from Unichem's Ghaziabad plant.
Shares of the company declined Rs 0.65, or 0.23%, to trade at Rs 279.30. The total volume of shares traded was 8,597 at the BSE (3.46 p.m., Monday).