Healthcare Industry News:  familial hypercholesterolemia 

Biopharmaceuticals Generics FDA

 News Release - December 21, 2006

Ranbaxy Granted Final FDA Approval to Market Simvastatin 5, 10, 20 and 40 mg Tablets

Cholesterol-Lowering Simvastatin Currently Marketed in the U.S. as Zocor (R)

PRINCETON, N.J., Dec. 21 (HSMN NewsFeed) -- 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 ZocorŪ 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


Source: Ranbaxy

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