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2007/8/30

Diet drug Acomplia gets reprieve in Europe

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@ 08:10 AM (11 months, 2 hours ago)

Diet drug Acomplia (rimonabant) was discussed by European regulators at their June meeting this week, but the only decision reached was to discuss the matter again at their July 16-to-19 meeting.

http://www.freewebs.com/acomplia

The Committee for Medicinal Products for Human Use of the European Medicines Agency, which approved Acomplia for sale in Europe more than a year ago, said it will continue to review data on the diet drug, which has been purchased by more than 100,000 Europeans.

The agency's discussion of Acomplia this week followed the overwhelming vote by the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee last week to recommend against sale of the diet drug in the United States based on currently available safety date.

The advisory panel's vote was based on newer data presented by FDA staff -- including data from post-marketing reports on usage in Europe. The FDA is expected to go along with that recommendation in the next several weeks.

While Acomplia for the moment will remain on sale in European Union countries on the same basis as it has been for the past year, the EMEA is expected to want to continue hearing about neurological and psychiatric side effects associated with the drug, including depression and suicidality.

Resources: http://www.acompliareport.com

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