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Old 04-09-2006, 08:38 PM   #1 (permalink)
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Join Date: Apr 2005
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FDA Finds Low-Dose Xenical (Alli) 'Approvable' for Over-the-Counter Sale

A half-strength version of the prescription weight-loss drug Xenical (orlistat) moved another step closer to becoming available over-the-counter when GlaxoSmithKline announced on April 7th that it had received an "approvable" letter for Alli from the U.S. Food and Drug Administration.

An "approvable" letter means certain issues still need to be resolved prior to FDA action, and Steven L. Burton, vice president of weight control products for Glaxo, declined to elaborate on what was holding up FDA approval except to say the agency did not ask for additional human testing.

Burton said the company was entering discussions with the FDA to address its additional questions, and expressed optimism that Alli (pronounced Al-EYE) could be in drugstores later this year, becoming the first FDA-approved diet drug product sold without a prescription.

Glaxo had previously been expressing optimism that Alli would be on the market before mid-summer.


http://www.allireport.com/News/news-040706.htm

My one main concern about this medication being made available OTC is with it being abused by people that do not need to loose weight. Yes, everyone has become obsessed with their weight. I myself have been struggling to loose the last 10 pounds from my pregnancy with twins. How do we prevent this medication from falling into the hands of teenage girls suffering from eating disorders such as anorexia? Will their be an age limit to purchase this medication? Will a person have to receive drug counseling from a pharmacist before they are allowed to purchase this medication? I am curious to hear your feelings on this matter are.
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