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France, Ireland oppose Mysimba EU approval on safety/efficacy grounds

This article was originally published in Scrip

Executive Summary

The EU CHMP's decision to recommend approval of Orexigen's weight loss combination product Mysimba (naltrexone/bupropion) has come under fire from the French and Irish regulatory agencies, whose representatives voted against the product's approval on safety and efficacy grounds at the committee's December meeting and have detailed their objections in a written statement.


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