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US regulators approve ‘female Viagra’

– Failed before –

In June, an advisory panel to the Food and Drug Administration urged regulators to approve flibanserin, after previously voting against it twice in years past.

The FDA is not required to follow the advice of the panel, but it often does.

Attempts to bring the drug to market failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.

According to documents on the FDA website, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.

“It has been a remarkable journey to get to this breakthrough moment. Today, we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” said Cindy Whitehead, chief executive officer of Sprout.

“We applaud the FDA for putting the patient voice at the centre of the conversation and for focusing on scientific evidence.”

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