Ranbaxy Laboratories Limited has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg, claimed a company press release.
Simvastatin Tablets are indicated for patients with coronary heart disease and hypercholesterolemia to reduce the risk of total mortality by reducing coronary death; reduce the risk of non-fatal myocardial infarction; reduce the risk for undergoing myocardial revascularization procedures; and reduce the risk of stroke or transient ischemic attack.
It is indicated to reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb), for the treatment of patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia), for the treatment of 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 (e.g., LDL apheresis) or if such treatments are unavailable.
Commenting on the development, Jim Meehan, Vice President, Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, stated that “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 organization 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."
Dipak Chattaraj, President, RPI, said "The product illustrates Ranbaxy's ability to develop products from API to formulation to manufacturing and finally commercialization, which truly fits the definition of a fully integrated pharmaceutical company".
Total sales for the Simvastatin Tablet market are $4.2 billion (IMS - MAT: June 2003).