Ranbaxy Laboratories Limited
(RLL), announced today that the Company has received approval from the U.S.
Food and Drug Administration (FDA) to manufacture and market Simvastatin
Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. The FDA's Office of
Generic Drugs has determined Ranbaxy's Simvastatin Tablets USP, 5 mg, 10
mg, 20 mg and 40 mg to be bioequivalent, therefore, therapeutically
equivalent to the listed drug Zocor(R) Tablets, 5 mg, 10 mg, 20 mg and 40
mg of Merck Research Laboratories. Total annualized market sales for
Simvastatin were $4.8 billion, of which $4.2 billion were for the 5 mg, 10
mg, 20 mg and 40 mg tablets (IMS - MAT: September 2006).
Simvastatin 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). A Simvastatin regimen
can be started simultaneously with diet.
"Ranbaxy has marketed the 80 mg tablets of Simvastatin on an exclusive
basis since the patent expired in June of this year. We are now in a
position to expand our product offerings to include the four additional
strengths of Simvastatin and can now offer the complete line of marketed
strengths for this product to our customers. Simvastatin has assumed a
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 U.S. healthcare system," according to Jim Meehan, Vice President
of Sales and Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a
wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's
largest pharmaceutical company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated,
research based, international pharmaceutical company producing a wide range
of quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued focus on
R&D has resulted in several approvals in developed markets and significant
progress in New Drug Discovery Research. The Company's foray into Novel
Drug Delivery Systems has led to proprietary "platform technologies,"
resulting in a number of products under development. The Company is serving
its customers in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances, ground operations in
49 countries and manufacturing operations in 9 countries.
Zocor is a registered trademark of Merck Research Laboratories
Ranbaxy Laboratories Limited
ranbaxy
View drug information on Zocor.