Healthcare Industry News:  otitis media 

Biopharmaceuticals Generics FDA

 News Release - December 14, 2006

Ranbaxy Is Granted Final Approval to Manufacture and Market Cefprozil Anti- Infective Tablets

PRINCETON, N.J., Dec. 14 (HSMN NewsFeed) -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Cefprozil Tablets USP, 250 mg and 500 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug CefzilŪ Tablets, 250 mg and 500 mg, respectively, of Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil Tablets were $76.6 million (IMS - MAT: September 2006).

Cefprozil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including: Pharyngitis/tonsillitis, otitis media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated skin and skin-structure infections.

"Ranbaxy is pleased to be granted approval for Cefprozil tablets which represents yet another addition to our ever-growing product portfolio of anti- infectives that will be available as an affordable generic alternative to the brand equivalent. This formulation will be produced in our cGMP compliant, cephalosporin dedicated facility located in Dewas, India. Our plans are to bring this product to the market in early 2007 during the height of the respiratory season," 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 8 countries.

* CefzilŪ is a registered trademark of Bristol Myers Squibb Company Pharmaceutical Research Institute

Source: Ranbaxy

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