Ranbaxy gets USFDA nod for generic Ceftin

New Delhi, Feb. 7

Ranbaxy Laboratories Ltd has received US Food and Drug Administration approval to make and sell the generic version of GlaxoSmithKline’s anti-infective Ceftin, which will be the first generic formulation in the market.

According to the company, the Office of Generic Drugs, USFDA has determined the two strengths of Ranbaxy’s formulations of Cefuroxime Axetil for Oral Suspension USP, or generic Ceftin to be bioequivalent and have the same therapeutic effect as that of GSK’s drug. Total annual market sales for Cefuroxime Axetil suspension were $28.7 million.

The drug is meant for the treatment of paediatric patients between three months and 12 years with mild to moderate bacterial infections such as pharyngitis or 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 the Cefuroxime 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 Mr Jim Meehan, Vice-President, Sales and Distribution for RPI, US, in a release.

Taken from Business Line

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