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Published on 14 May 2009

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Heartburn remedy approved by FDA

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Novartis announced today that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the US Food and Drug Administration (FDA) as the first over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn since 2003. Prevacid 24HR is expected to be available over-the-counter in 2009.

Once-daily Prevacid 24HR is the first OTC PPI approved in its original prescription formulation. It is the only PPI containing the active ingredient lansoprazole to be approved for OTC treatmentof frequent heartburn, which is defined as heartburn that occurs two or more days per week.

In three clinical studies, Prevacid 24HR demonstrated significantly better efficacy in treating frequent heartburn than placebo. Although some people experienced complete relief of symptoms within 24 hours, it may take one to four days for full effect.

The prescription medicine Prevacid (lansoprazole), a brand that 21 million patients have trusted to treat their acid-related disorders, is one of the top five prescription brands in the US in terms of total prescription dollar sales. The drug achieved $3.37 billion in annual sales in the US in 2008. Novartis has licensed the Prevacid  trademark and certain other intellectual property rights for OTC development and commercialisation from Takeda Pharmaceuticals North America, Inc.

“Our partnership with Takeda Pharmaceuticals on this switch has been outstanding,” said Larry Allgaier, Global Head of the Novartis OTC Business Unit.

“Takeda Pharmaceuticals trusted Novartis to take this leading product over-the-counter because of our core competencies as a pharmaceutical company, and our demonstrated history of success taking prescription products over the counter, providing consumers with greater convenience and broader access to the effective treatments they need, while continuing to build the brands.”

Prescription-strength Prevacid 24HR treats frequent heartburn for a full 24 hours. Prevacid 24HR works by stopping the release of acid into the stomach.

“This is an important development for the 50 million American adults who suffer from frequent heartburn,” said M. Brian Fennerty, MD, Professor of Medicine, Division of Gastroenterology, Oregon Health and Science University. “Prescription strength Prevacid 24HR will be both an effective and well-tolerated option for treating frequent heartburn.”

The FDA approved Prevacid 24HR in the form of 15mg delayed-release capsules. Prevacid 24HR is a 14-day course of treatment and should be taken once per day before eating in the morning to treat frequent heartburn.

Novartis



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