FDA Approves Addyi, Rejects Gender Discrimination Claims
This article was originally published in RPM Report
FDA knew its decision on whether to approve the first treatment for female sexual dysfunction would be controversial. The Division Director's memo explaining the decision and acknowledging the controversy makes for interesting reading.
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Advisory committee votes 18-6 to recommend approval of the female sexual dysfunction drug contingent on a risk management plan, despite unease about modest efficacy and risks such as fainting.