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 Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL. 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 Ceftin® by GlaxoSmithKline. Total annual market sales for Cefuroxime Axetil Suspension were $28.7 million (IMS – MAT: December 2007).

Cefuroxime Axetil Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media and Impetigo.

“Ranbaxy is pleased to receive this approval for Cefuroxime Axetil Suspension that now allows us to offer both dosage forms for a product that is highly prescribed. We will offer Cefuroxime Axetil Suspension as a pleasant tasting liquid intended primarily for children that will ease in the acceptance and administration of this anti-infective. This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade,” said Jim Meehan, Vice President of Sales and Distribution 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 11 countries.


*Ceftin® is a registered trademark of GlaxoSmithKline

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