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Various women groups praised the FDA decision as another step towards gender equality, as the federal agency has already approves 25 male drugs for sexual dysfunction.
The Food and Administration panel has recommended approval of flibanserin, the women’s Viagra, by vote of 18-6. But, a key requirement is that certain steps to be taken to reduce the drug’s risk.
Prescribed doctors might be required to inform their patients of the possible side effects of lady Viagra, such as nausea, dizziness and fainting. Physicians must also be required to receive a certification to prescribe flibanserin.
Women groups have been fighting for FDA approval of the female Viagra, under the program named Even the Score. It has accused the federal agency for gender bias because it had approved several sexual medications for men, but none for women.
FDA has twice rejected the women’s sex enhancer pills. However the third time’s a charm rule seemed to world, due to factors such as new data about flibanserin clinical trials.
Developer of the Viagra for females, Sprout Pharmaciticals first failed to receive the FDA approval in 2010. Flibanserin was rejected again in 2013.
FDA could approve the female libido pill by Aug 18, the FDA deadline for making final decision on flibanserin.
Many of the FDA committee members said that they will vote yes for the approval of the women’s Viagra, but with reluctance. That is due to its average benefits and side effects.
Dr. Julia Heiman of Indiana University said that modest results can still have significant effect. That is due to severe clinical cases.
Supporters of flibanserin said that failing to approve female Viagra could result in various negative effects. Women could boost their sexual drive by purchasing off band drugs or suspect online supplements.