FDA Gives Interim OK for OTC Prilosec

Aug 22, 2002

Reuters reports that the U.S. Food and Drug Administration says it will approve sales of an over-the-counter form of heartburn drug Prilosec, but only with a label that consumers can understand. According to Procter & Gamble Co., it received an approvable letter from the FDA and expects to begin commercial nonprescription sales in the first half of next year.

P&G owns rights to an over-the-counter form of Prilosec, the “purple pill” produced by drug maker AstraZeneca Plc. Prilosec, which generates about six billion dollars a year in sales, was the world’s top-selling medicine before its patent protection expired last year.

“The approvable letter says final FDA clearance will be granted after a study is conducted to make sure that consumers understand the drug’s labeling,” says Dr. Greg Allgood, associate director of the Procter & Gamble Health Sciences Institute. If approved, the generic version of Prilosec would be the first in a class of drugs called proton pump inhibitors, which work by blocking the production of stomach acid, to become an over-the-counter medicine.

Moderator Comment: How can retailers maximize sales of the heartburn relief products category with the introduction of nonprescription Prilosec?

‘Rx to OTC’ is a magic phrase for retailers. At least,
for those who take advantage of the opportunity. [George
Anderson – Moderator

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