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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

Xenical May be Approved for Over The Counter Sales - Non-Prescription Version of Orlistat May Win Approval By The FDA

Xenical

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. 

 
 
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By Dan Wilson
Best Syndication

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Important:  The material on Best Syndication is for informational purposes only and is not a substitute for medical advice or treatment for any medical conditions. You should promptly seek professional medical care if you have any concern about your health, and you should always consult your physician before starting a fitness program.
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Copyright 2005 Best Syndication                   Last Updated Saturday, July 10, 2010 09:50 PM