FDA Issues Guidelines for Female Libido Pills after Learning Some Hard Lessons
October 31, 2016
(STAT News) – After a two-year wait, the US Food and Drug Administration finally issued new guidance for companies that want to develop drugs to bolster female libidos. But the details suggest the agency has belatedly learned some hard-fought lessons following complaints that the controversial Addyi pill did not warrant approval last year. The 15-page draft guidance, which was released Tuesday, offers a typical how-to for companies, but also points to certain steps that Sprout Pharmaceuticals did not follow as part of its Addyi marketing application to the FDA.