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  • Regulatory NewsRegulatory News

    FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

    Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released...
  • Regulatory NewsRegulatory News

    FDA Softens Stance on Drinking Alcohol With Female Libido Drug

    Following the completion of postmarketing studies for Sprout Pharmaceuticals’ Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. Specifically, the agency told women to discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip ...
  • Regulatory NewsRegulatory News

    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
  • Regulatory NewsRegulatory News

    Developing the Next Female Viagra? FDA Offers Draft Guidance With Caveats

    The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened the door for other companies to develop similar drugs. Now, FDA is trying to clarify what these drug developers racing to create the next female Viagra should focus on, with particular discussion of the challenges involved, including diagnostic criteria, endpoints and patient-reported outcome (PRO) instruments. Th...