Ranbaxy Receives USFDA Approval For Cefuroxime Axetil

Ranbaxy LabsIndia’s biggest pharma company, Ranbaxy Laboratories Ltd has announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Cefuroxime Axetil for Oral Suspension USP, 125 mg/5mL and 250 mg/5mL.

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. The drug is used in the treatment of Pharyngitis/Tonsillitis, Acute Bacterial Otitis Media and Impetigo.

The USFDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin® by GlaxoSmithKline.

The total annual sales for Cefuroxime Axetil Suspension as a prescription only product were US$ 28.7 million (IMS - MAT: December 2007).

Ranbaxy Laboratories had reported standalone net profit of Rs 301.60 crore for the quarter ended Dec 31, 2007, as compared with the previous year’s figure of Rs 201.03 crore. Its total income stood at Rs 1118 crore, as against 1035 crore for the same period, last fiscal.




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