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:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

AstraZeneca takes on pediatricians

The American Academy of Pediatricians says an AstraZeneca drug for preemies should be used less often, and the drugmaker is fighting back with an ad campaign that says the new guidelines put too many at risk.

UK generic use soared in 2013

Generics made up almost 75% of prescriptions in the United Kingdom last year.

GSK refutes consumer spin-off rumor

The company refutes a Financial Times rumor that one was happening soonish.