Xenical May be
Approved for Over The Counter Sales - Non-Prescription Version of
Orlistat May Win Approval By The FDA - Called Alli
April 7th 2006
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Xenical |
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The Food and Drug Administration (FDA) may approve an over the counter
(OTC) version of the prescription weight loss drug Xenical (orlistat).
The FDA issued an “approval letter” Friday which says the agency
believes the product is worthy of approval. Jennifer Corbett Dooren of
Marketwatch reported that there may be some conditions that need to be
met before the drug is allowed to market.
Xenical is marketed by Roche Holding AG, but the rights to the OTC
version were sold to the British firm, GlaxoSmithKline PLC's (GSK).
This is expected to be a weaker version of Xenical. The drug works by
preventing fat from being absorbed by the body. Some of the side
effects may include excess gas and an oily discharge.
If this drug ultimately wins approval, it would be the only weight loss
drug approved for OTC sales by the FDA. It is unknown what conditions
need to be met, but GSK said in a statement, "GSK Consumer Healthcare
will work with the FDA to address their comments and recommendations."
The company said that the drug will help fight soaring obesity rates in
the United States. This should make it easier for Americans to use the
drug. The competitor to Xenical, Meridia, is made by abbott
Laboratories. Meridia works by suppressing the appetite.
A report on NBC News raised the issue of caution concerning orlistat.
They said that the drug can also lead to hepatitis, gallstones and
kidney stones, although the exact cause is not clear. The agency went
on to say that experts have expressed concern that people will regain
the weight when they stop using the drug. Also, people may not be able
to tell if it is safe for them to use without a doctor’s advice.
By Dan Wilson
Best Syndication
Books on Dieting
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