FDA approves drug maker’s ‘female Viagra’ called Addyi

Addyi, Flibanserin
FILE - In this June 22, 2015, photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. The Food and Drug Administration on Tuesday, Aug. 18, 2015, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men. (AP Photo/Allen G. Breed)

RALEIGH, N.C. – A Raleigh company’s pill that some are calling a female version of Viagra was approved by the Food and Drug Administration the agency said late Tuesday afternoon.

The FDA was expected to rule Tuesday on the drug Flibanserin, which is made by the Raleigh-based company Sprout Pharmaceuticals.

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“The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women,” the agency said in a press release.

The prescription will become the first medication available to help improve the female libido.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

In June, an FDA advisory panel recommended the drug be approved after failing FDA approval twice, first back in 2010.

There are critics who argue not much has changed since 2010 and that the drug’s effect on the libido is not clear and side effects such as sleepiness and dizziness are problematic.

The drug must be taken daily over a period of weeks to become effective.

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