The USFDA granted approval to Ranbaxy Pharmaceuticals, Inc. to manufacture and market Simvastatin Tablets USP, 80mg with 180-day exclusivity in the United States.
Ranbaxy's 80mg Simvastatin Tablets USP is the bioequivalent and generic version of Merck’s Zocor® Tablets, 80mg, a cholesterol-lowering drug.
"Ranbaxy is pleased to receive FDA approval for this blockbuster drug. We expect to launch Simvastatin 80mg on an exclusive basis immediately.
We believe that by offering an affordably priced generic alternative, we will have a positive impact on the cost of healthcare for patients who have or at high risk of coronary heart disease," noted Jim Meehan, Vice President of Sales and Marketing for RPI.
Regimen with simvastatin can be started together with diet. These tablets are indicated in the treatment of patients with coronary heart disease (CHD) or at high risk of CHD, reductions in risk of CHD mortality and cardiovascular events, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH).
Source: Ranbaxy Press Release
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