Flibanserin fine by FDA committee, with a risk plan recommendation

An FDA advisory panel voted 18 to 6 in favor of approval of the Sprout Pharmaceuticals medicine called flibanserin (Girosa). The FDA usually follows the recommendations of the expert panels, but is not bound to do so.

The recommendation for approval also came wirth some guidance. The committee suggested a plan to limit safety risks, something which is not unusual these days.


More to follow as this medicine moves toward aproval. I'll include this in the upcoming Essential Guide To Prescription Drugs and may complete a new eBook on it.

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