Each year, the U.S. Food and Drug Administration (FDA) sees hundreds of applications for new medications. In many cases, the FDA will reject the drug due to, among other reasons, product safety concerns. According to a recent article in Fierce Biotech, the FDA recently put its seal of approval on flibanserin, “a first-of-its-kind pill designed to boost women’s sexual desire, but not without sticking a black-box safety warning on the twice-rejected drug.” In other words, the FDA previously rejected flibanserin upon two separate applications, and it has now only approved the drug with significant safety warnings attached.
First Drug of Its Kind Comes with Significant Side Effects
The recently approved drug, flibanserin, was manufactured by Sprout Pharmaceuticals and will be sold under the brand name Addyi. It’s designed to “help premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD) regain their sex drives by boosting dopamine and norepinephrine levels in the brain.” When the FDA previously rejected the drug, it emphasized that some serious safety issues existed with the medication. Taking note, Sprout Pharmaceuticals conducted more studies and has now seen the drug approved for consumer use.