FDA Panel Votes to Approve Female Viagra With Conditions After Third Hearing
Jun 4, 2015, 5:09 PM ET
By GILLIAN MOHNEY and LANA ZAK
via GOOD MORNING AMERICA
An expert panel for the U.S. Food and Drug Administration voted today to approve a drug that has been dubbed the "female Viagra" after two previous attempts failed to gain approval.
The FDA is set to make a final decision in August, and while the agency generally follows to the panelists vote, it is not bound to adhere to it.
Medical experts from the FDA examined the evidence on the effectiveness of the drug flibanserin, designed to help pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD).
This is the third time the drug has been presented to the FDA, after previous attempts to get the drug approved failed in part due to the agency having concerns about whether its benefits outweighed the risks.
A mother and her daughter were among those to offer emotional testimony to the FDA panel today. The mother, Barbara, talked about how her relationships with her husband and family became strained because of her lack of a sex drive. She said she was diagnosed with HSDD and told the panel that she was "so relieved to know this was not my fault." She was on the clinical trial and said the results were dramatic, "no negative side effects, just good ones, really good ones."
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