Ranbaxy Gets USFDA Nod For Heart Drug

New Delhi: | Updated: Sep 30 2003, 05:30am hrs
Ranbaxy Pharmaceuticals Inc (RPI), a wholly-owned US subsidiary of Ranbaxy Laboratories, has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market Simvastatin tablets USP of 5mg, 10 mg, 20 mg, 40 mg, and 80 mg strength.

A $4.2 billion drug, Simvastatin (ZocorR of Merck) is prescribed for patients with coronary heart disease and hypercholesterolemia to reduce the risk of total mortality by lowering coronary death, risks of non-fatal myocardial infection, risks in undergoing myocardial revascularisation procedures as well as lower the risk of strokes or transient ischemic attacks.

ZocorR is used for lowering elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients suffering from primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb), for treating patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia), patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia), and is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

According to RPI vice-president, sales and marketing, Jim Meehan: The opportunity to market Simvastatin clearly establishes RPI as one of the leading pharmaceutical companies to provide a generic alternative for a product that has had a dramatic impact in managing patients with hyperlipidemia and the associated effects of this condition. This product adds both recognition and credibility to the Ranbaxy organisation as a leader in the generic pharmaceutical market place.

The product will be made available by RPI under the Ranbaxy label through wholesalers, distributors and pharmacies on a nationwide basis upon final approval, he added.

RPI president, Dipak Chattaraj, said, The product illustrates Ranbaxys ability to develop products from API to formulation to manufacturing and finally commercialisation, which truly fits the definition of a fully integrated pharmaceutical company.