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Video: Novartis Receives Approval From FDA to Market Prevacid(R) 24HR as First and Only OTC Proton Pump Inhibitor in Original Prescription Formulation
Date:5/14/2009

- This approval will provide greater convenience and broader access to an effective treatment option to the 50 million Americans(1) suffering from frequent heartburn

- Once-daily, prescription-strength Prevacid(R) 24HR is the first OTC proton pump inhibitor approved for the treatment of frequent heartburn in the US since 2003

- Prescription-strength Prevacid 24HR treats frequent heartburn for a full 24 hours

BASEL, Switzerland, May 14 /PRNewswire/ -- Novartis announced today that Prevacid(R) 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the U.S. 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.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/prevacid/38457/

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 treatment of 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(R) (lansoprazole)(2), a brand that 21 million patients have trusted to treat their acid-related disorders(3), is one of the top five prescription brands in the U.S. in terms of total prescription dollar sales(4). The drug achieved $3.37 billion in annual sales in the U.S. in 2008(5). Novartis has licensed the Prevacid(R) trademark and certain othe
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SOURCE Novartis
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