Unichem Laboatories’ Valsartan tablets receives ANDA approval

To treat hypertension, heart failure (NYHA class II – IV) and reduces cardiovascular mortality in clinically stable patients

Unichem Laboatories Limited has recently announced that it has received ANDA approval from United States Food and Drug Administration (US FDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, which are therapeutically equivalent to DIOVAN (Valsartan) tablets, 40 mg, 80 mg, 160 mg and 320 mg of Novartis Pharmaceuticals Corp. Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker 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 strokes and myocardial infarctions
• Treatment of heart failure (NYHA class II – IV); Valsartan tablets sigificantly 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 commercialised from Unichem’s Ghaziabad plant.