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Recommendation on Flibanserin Announced

Jun 05, 2015

On Thursday, June 4, an advisory panel to the U.S. Food and Drug Administration recommended approval of flibanserin, a drug intended to treat hypoactive sexual desire disorder (HSDD) in women. 
 
HSDD is a chronic lack of sexual desire accompanied by distress. It is estimated to affect one in ten women. 
 
Approval of flibanserin has been rejected by the FDA twice already because of safety concerns.  The panel's recommendation does not mean the drug is approved. However, the FDA usually follows advisory panel decisions.
 
The committee recommended certain provisions for approval.  Only certified doctors would be able to prescribe flibanserin and pharmacies would need to confirm certification. The panel also suggested that safety studies continue.