Press Announcements > FDA orders important safety labeling changes for Addyi

Press Announcements > FDA orders important safety labeling changes for Addyi

FDA orders important safety labeling changes for Addyi

The U.S. Food and Drug Administration today issued a safety labeling change order to 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 ...

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