Prilosec Manufacturers to Ask FDA to Approve Heartburn Drug for Over-the-Counter Sales
AztraZeneca and Procter & Gamble will ask an FDA advisory panel next month to approve the companies' heartburn drug Prilosec for over-the-counter sales, USA Today reports. The move is the second attempt by the drug's co-marketers to sell Prilosec, the world's top-selling drug last year, over the counter. An FDA advisory committee rejected a request in October 2000 to sell a 10-day course of the 10-milligram dose to treat heartburn. This time, the companies want to sell a 14-day course of the 20-mg dose -- the same as the prescription version but at one-third of the cost, according to Greg Allgood, associate director of Procter & Gamble's Health Sciences Institute. Sales of Prilosec, which also treats ulcers and acid reflux disease, totaled $4.9 billion in 2001, but the drug lost its main patent protection in October, and AstraZeneca is now battling several manufacturers to keep generic versions off the market. It is also hoping to switch Prilosec users to its new heartburn treatment, Nexium, USA Today reports. AstraZeneca's push for OTC status is similar to Schering-Plough's decision to embrace OTC sales of its blockbuster allergy drug Claritin. Schering-Plough is trying to shift Claritin users to Clarinex. In both cases, "skeptics question whether the newer heavily marketed drugs are much different from their predecessors," USA Today reports. If the FDA approves Prilosec for OTC sales, it would be a "huge boon for frequent heartburn sufferers," Mark Fendrick, professor of health management and policy at the University of Michigan, said (Rubin, USA Today, 5/30).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.