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FDA orders important safety labeling changes for Addyi

April 11, 2019 / FDA

The U.S. Food and Drug Administration today issued a safety labeling change orderto Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result of the FDA’s review of postmarketing studies, including one required of Sprout when Addyi was approved in August 2015, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, as well as other data. “The FDA helps ensure that the most current safety information about the use of prescription drugs is accurately reflected in product labeling, giving health care professionals and patients confidence that they are able to make the most informed treatment decisions,” said Julie Beitz, M.D. director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research’s Office of ...