FDA to consider Xenical as first OTC weight-loss drug in U.S.

Share this article:
An FDA advisory panel is scheduled to meet in late January to review GlaxoSmithKline's (GSK) application to sell a non-prescription, 60-milligram dose of its anti-obesity drug Xenical (orlistat).
GSK submitted the New Drug Application for OTC status in June after acquiring non-prescription marketing rights from Roche in June 2004 for $100 million.
Xenical, which blocks some fat from being absorbed by the body, is currently available without a prescription in Australia and New Zealand.
But in those countries, Xenical falls into a third category of drugs available only from a pharmacist. The U.S. currently has no "behind-the-counter" policy.
GSK has suggested working with retailers to verify the age of people who want to purchase an OTC form of Xenical, similar to the approach the company has taken with its Nicorette and NicoDerm CQ, used to help smokers quit.
GSK said in published reports that it expects Xenical to be available in an OTC format by mid-2006.
But heightened concern about drug safety post-Vioxx could be a major hurdle to Xenical to overcome in its OTC bid.
In January 2005, an FDA advisory panel voted 20-3 against recommending an OTC version of Merck's cholesterol drug Mevacor, after the company failed to demonstrate that consumers could decide on their own to properly take the drug.
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.