FDA approves OTC Prilosec

September 1, 2003

Pharmaceutical Representative

The Food and Drug Administration has announced the approval of Wilmington, DE-based AstraZeneca LP and Cincinnati-based Procter & Gamble Co.'s Prilosec.

The Food and Drug Administration has announced the approval of Wilmington, DE-based AstraZeneca LP and Cincinnati-based Procter & Gamble Co.'s Prilosec® (omeprazole) for over-the-counter treatment of frequent heartburn.

Unlike the two classes of currently marketed over-the-counter heartburn treatments, antacids and acid reducers, Prilosec OTC is indicated for the treatment of frequent heartburn, which is classified as heartburn that occurs two or more days per week.

"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 healthcare business. "Prilosec OTC will be available on store shelves nationally this fall, offering consumers an effective and affordable treatment for their frequent heartburn."

Prescription Prilosec, which was first approved by the FDA in 1989, will remain available as a treatment for diseases that require diagnosis and supervision by a doctor, such as gastroesophageal reflux disease, inflammation of the esophagus and ulcers.

The over-the-counter version of Prilosec, which will be marketed by Proctor & Gamble only, will be available in a delayed-release 20 mg tablet that must be taken before eating once a day, every day for 14 days.

Because of the safety studies performed by Procter & Gamble, the product will have three years of over-the-counter exclusivity. Makers of generic versions of the prescription product will not be able to market an over-the-counter version until the marketing exclusivity has expired. PR

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