FDA gives OK to Wockhardt's anti-ulcer drug Ranitidine

By Lisa Kerner

Erie, Pa., Feb. 27 - Wockhardt Ltd. said the Food and Drug Administration has approved marketing Ranitidine 75 mg tablets as an over-the-counter product in the United States.

Ranitidine is the generic version of Pfizer's Zantac 75 tablets.

The company's U.S. subsidiary, Wockhardt USA Inc., is expected to launch the anti-ulcer drug shortly, according to a company news release.

IMS data puts the current market for this type of product in the United States at $61 million.

"Wockhardt is already a major player in the U.S. Ranitidine prescription market, with its 150 mg and 300 mg tablets," executive director Lalit Kumar said in the release.

"The prescription tablets launched in 2002 have steadily increased their market shares. With the addition of the OTC version, we will now have the full range of Ranitidine medications in the United States."

This is the second abbreviated New Drug Application approval for Wockhardt this year.

The company has another 21 applications pending with the FDA.

Wockhardt is a technology-driven pharmaceutical and biotechnology company based in Maharashtra, India.

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