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HealthFDA

‘Female Viagra’ could get approval today

By
Michal Addady
Michal Addady
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By
Michal Addady
Michal Addady
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August 18, 2015, 11:22 AM ET
Pharmaceuticals, Viagra
Pharmaceuticals, Viagra , Pharmaceuticals, Viagra . (Photo by: Universal Education/Universal Images Group via Getty Images)Photograph by Getty Images

The U.S. Food and Drug Administration is expected to make a decision today about whether or not to approve the “female Viagra pill,” Flibanserin, CBSreports.

The purpose of Flibanserin, developed by Sprout Pharmaceuticals, is to increase sexual desire in premenopausal women. It works by stimulating hormones in the brain that are related to sexual desire. The FDA has previously rejected the drug twice because it believed that the side effects did not justify the benefits.

Eleven members of Congress wrote to Margaret Hamburg, the Commissioner of the FDA, to urge the association to approve the drug. In it they noted that side effects for the pill include “fatigue, nausea, sleepiness, difficulty sleeping, dizziness, and dry mouth.” The side effects for FDA approved medications that treat male sexual dysfunction include “prolonged erection, blindness, heart attack, and stroke.”

In June, an FDA advisory committee voted 18-6 to recommend approval for the drug on the condition that risky side effects be minimized.

There are currently 26 FDA approved drugs to treat male sexual dysfunction. If Flibanserin is approved today, it will be the first-ever FDA approved drug to treat female sexual dysfunction.

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By Michal Addady
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