FDA Panel Recommends Approval of Flibanserin
June 5, 2015
Yesterday [June 4, 2015], an FDA advisory panel recommended the approval of flibanserin, a drug developed for hypoactive sexual desire disorder (HSDD), in the United States.
It is thought that 10% of women have HSDD, a persistent lack of sexual desire and interest that brings distress to women, partners, and relationships.
The FDA had rejected flibanserin twice due to concerns about safey and effectiveness.
The drug has still not been approved by the FDA, but the agency often follows recommendations from advisory committees.
The recommendation does come with risk management suggestions, however.
Risk management proposals included that flibanserin be prescribed only by certified physicians and that pharmacies verify that certification before dispensing the drug.
The panel also called for continued safety studies.