The FDA’s Office of Generic Drugs has determined Ranbaxy’s simvastatin to be bioequivalent to the listed drug Zocor manufactured by Merck Research Laboratories.
Total annualized market sales for simvastatin were $4.8 billion, according to Ranbaxy.
Simvastatin tablets are indicated in the treatment of patients with coronary heart disease, patients with hypercholesterolemia and adolescent patients with heterozygous familial hypercholesterolemia.
“Simvastatin has assumed prominent position in the management of patients with hypercholesterolemia, and is now available as an alternative to the brand at an affordable price. This undoubtedly will have a positive economic benefit to patients, as well as to the US healthcare system,” said Jim Meehan, vice president, Sales and Marketing for Ranbaxy.