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FDA Approves Ranbaxy’s Generic Ceftin
The FDA’s Office of Generic Drugs has approved Indian drugmaker Ranbaxy Laboratories’ generic pediatric formulation of the antibiotic cefuroxime axetil, which is marketed by GlaxoSmithKline (GSK) under the brand name Ceftin. The drug is indicated for the treatment of mild to moderate pharyngitis/tonsillitis, acute bacterial otitis media and impetigo in patients 3 months to 12 years old. The FDA has approved Ranbaxy to market both the 125-mg/5mL and the 250-mg/5mL doses. Total annual sales of the drug were $28.7 million last year, according to the company. |
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