Ranbaxy gains approval to manufacture & market Cefuroxime Axetil for Oral Suspension in USA
Ranbaxy Laboratories Ltd on February 06, 2008 has announced that the Company 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, which will be the first generic formulation on the market. 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 be the only generic Company to offer both dosage forms for a product that is highly prescribed. We will offer Cefuroxime Axetil Suspension as liquid intended primarily for children that will ease in the 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, USA.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL). RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.