Manufacturers of "female Viagra" flibanserin appeal FDA denial

December 11, 2013 7:55 PM

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Manufacturers of "female Viagra" flibanserin appeal FDA denial

The manufacturer of a potential “female Viagra” is appealing the Food and Drug Administration's letter denying the drug's approval, saying the company has gone above and beyond what is necessary to prove its treatment works and is necessary for many women.

Sprout Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for flibanserin in October. At that time, the company said FDA asked for more information before the agency approved the drug for the U.S. market.

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