The Hindu Business Line : FDA nod for Wockhardt's Ranitidine

Wockhardt Ltd has received the United States Food and Drug Administration (USFDA) approval to market ulcer drug Ranitidine 75 mg tablets as an over-the-counter (OTC) product in the US market.

Ranitidine is the generic version of Pfizer's Zantac 75 tablets. Wockhardt USA Inc is expected to launch the anti-ulcer drug shortly, the company told the Bombay Stock Exchange. The current size of the Ranatidine market is estimated at $61 million. "Wockhardt is already a major player in the US Ranitidine prescription market, with its 150 mg and 300 mg tablets," the company's Executive Director, Mr Lalit Kumar, said.

This is Wockhardt's second ANDA (abbreviated new drug application) approval in 2006. The US became Wockhardt's fastest growing market in 2005, recording a 50 per cent growth in formulation sales. Ranitidine OTC will be the 12th product to be marketed by Wockhardt under its banner in the US and the second OTC drug after famotidine.

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