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