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Wockhardt gets US FDA nod for antibiotic drug

Our Bureau

Mumbai , Aug 2

WOCKHARDT Ltd has got approval from the US Food and Drug Administration (US FDA) for marketing the antibiotic cefuroxime axetil in the US market.

Cefuroxime axetil, the chemical equivalent of GlaxoSmithKline's Ceftin, is the sixth Wockhardt product to be marketed in the US, the company said.

Wockhardt USA Inc, the company's US subsidiary, will launch the broad-spectrum cephalosporin antibiotic tablets in three strengths — 125 mg, 250 mg and 500 mg — over the next few weeks, a company note said here today. The current US market for this product is $58 million. "New product launches will drive business in the US, which is Wockhardt's fastest growing market," the Wockhardt Chairman, Mr Habil Khorakiwala, said. "Our US formulation business grew over 150 per cent in the first half of 2005 and we have another 12 applications pending with the US FDA," he added.

Ranbaxy is already facing sales and pricing pressure on this drug, an analyst said. Wockhardt improved its market share for two key products in the US in recent months — bethenechol chloride and enalapril, the company said.

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