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US approves Novartis heartburn drug for OTC sale
May 14, 2009 / 5:20 AM / 9 years ago

US approves Novartis heartburn drug for OTC sale

* Novartis says FDA approves Prevacid 24HR for OTC sales

* Drug expected to be available over-the-counter in 2009

ZURICH, May 14 (Reuters) - Swiss drugmaker Novartis AG NOVN.VX said on Thursday its gastric acid reflux drug Prevacid 24HR is likely to be available to buy over the counter this year after it got backing from the U.S. Food and Drug Administration.

The FDA has approved Prevacid 24HR as the first over-the-counter proton pump inhibitor for the treatment of frequent heartburn since 2003, Novartis said in a statement.

“This approval will provide greater convenience and broader access to an effective treatment option to the 50 million Americans suffering from frequent heartburn,” the firm said.

Frequent heartburn, which can cause a burning sensation in the chest and in the throat, a bitter taste in the mouth and asthma-like symptoms, is defined as heartburn that happens at least twice a week.

The prescription medicine Prevacid is one of the top five prescription brands in the U.S. in terms of total prescription dollar sales and it had annual sales of $3.37 billion in the U.S. in 2008.

Novartis has licensed the Prevacid trademark and certain other intellectual property rights for OTC development and commercialization from Takeda Pharmaceuticals North America, Inc. (4502.T) (Reporting by Katie Reid; Editing by Greg Mahlich)

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