OTC Prevacid®, Heartburn Medicine Now FDA-Approved

Filed in archive FDA Approvals on May 15, 2009

More than 50 million Americans suffer from frequent heartburn, and nearly half-more than 21 million patients-utilize prescription-only Prevacid® to treat acid-related disorders.

The US FDA recently announced its approval of Prevacid® 24HR, the first over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn approved in the US since 2003. Prevacid 24HR is taken once daily over a 14-day course of treatment, and has been clinically shown to provide relief from heartburn for 24 hours. In three clinical studies, comparing the product to placebo over a 14-day course of treatment, the product showed significantly better efficacy in treating frequent heartburn than placebo.

• his approval will provide greater convenience and broader access to an effective treatment option to the 50 million Americans1 suffering from frequent heartburn


• Once-daily, prescription-strength Prevacid® 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

When doctor visits and medication costs are taken into account, Prevacid 24HR may save consumers time and money. Recent research, from the Consumer Healthcare Products Association (CHPA) and The Nielsen Company, estimates that the availability of OTC heartburn medications saves each consumer an average total of $174 annually in prescription and office visits. CHPA and Nielsen attribute $757 million in annual savings to the US healthcare system from the availability of OTC heartburn medications based on fewer office visits.

Prevacid and Prevacid 24Hr OTC are both products of Novartis.