As indicated last month, we will probably soon have our first over the counter proton pump inhibitor - FDA gives conditional OK to nonprescription Prilosec

THE COMPANY said it received a so-called approvable letter from the FDA and now expects to begin commercial nonprescription sales of the drug 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 $6 billion 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, said Dr. Greg Allgood, associate director of the Procter & Gamble Health Sciences Institute.

I have mixed feelings about this announcement. The financial implications are probably very positive. History suggests that patients will pay less for an OTC drug. However, I do worry about patients figuring out when to come in for evaluations - especially with chronic gastroesophageal reflux.