Prilosec (omeprazole), one of the world's top-selling prescription drugs in its class, was approved by the U.S. Food and Drug Administration for sale over-the-counter (OTC) to treat frequent heartburn. Marketed by The Procter & Gamble Company as Prilosec OTC (omeprazole magnesium delayed release tablets), it is the first of a new class of OTC heartburn medicine called proton pump inhibitors. Prilosec OTC will be offered to consumers at a 20 mg dose, which is the most commonly written strength for prescription Prilosec that continues to be available.

Prilosec OTC is the only over-the-counter therapy specifically indicated for the treatment of frequent heartburn, or heartburn that occurs two or more days per week. Over 50 million Americans suffer from frequent heartburn (2003 National Heartburn Alliance Survey).

"Prilosec OTC represents a huge win for the millions of consumers searching for a new way to treat their frequent heartburn," said Joe Arcuri, general manager of Procter & Gamble's Personal Health Care business. "Prilosec OTC will be available on store shelves nationally this fall offering consumers an effective and affordable treatment for their frequent heartburn."

"Prilosec OTC works unlike current OTC products," said Greg Allgood, associate director, Procter & Gamble Health Sciences Institute. "It's the only OTC medication that reduces the amount of heartburn-causing acid by shutting down active acid-producing pumps at the source."

The FDA decision reflects prescription Prilosec's 15-year safety and efficacy track record. In addition, more than 18,000 people have participated in clinical trials for over-the-counter approval. From 1996 to 2000, Prilosec was the top-selling prescription medication in the world with more than 10 million patients taking it during that period.

Prilosec OTC is being brought to the over-the-counter market through an alliance between P&G and AstraZeneca. AstraZeneca will continue to make prescription Prilosec and its other acid inhibitor, Nexium (esomeprazole magnesium), for the treatment of heartburn associated with gastroesophageal reflux disease (GERD) and other acid-related diseases.