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FDA gives Glaxo tentative OK for OTC diet drug

April 7, 2006

WASHINGTON (Reuters) – GlaxoSmithKline has received
conditional approval for over-the-counter sales of the
weight-loss drug Xenical, a U.S. Food and Drug Administration
spokeswoman said on Friday.

The British drugmaker received a letter from the FDA on
Thursday for the drug, which would be sold under the brand name
Alli, FDA spokeswoman Laura Alvey said. She did not say what
steps the company must take before it can win final approval.

Glaxo bought U.S. rights for nonprescription sales of
Xenical from Roche Holding AG last year. Roche, the drug’s
maker, already sells Xenical by prescription.

Representatives for Glaxo could not be immediately reached
for comment.

Known generically as orlistat, the pill helps prevent fat
from being absorbed by the body but can cause excess gas and
oily discharge.

If it wins final approval, it would be the only
FDA-endorsed weight-loss drug available without a prescription.

Company officials have said nonprescription sales would
help fight soaring obesity rates in the United States, making
it easier for overweight Americans to seek treatment.

But some experts have expressed concern about people
regaining weight after they stop using the drug, as well as
whether people will be able to tell if it is safe for them
without a doctor’s advice.

The drug can also lead to hepatitis, gallstones and kidney
stones, although the exact cause is not clear.

Orlistat is one of two main prescription obesity drugs on
the U.S market. Its rival, Abbott Laboratories Inc’s Meridia,
suppresses appetite.


Source: reuters



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