FDA approves female sexual dysfunction drug

@article{Mullard2015FDAAF,
  title={FDA approves female sexual dysfunction drug},
  author={Asher Mullard},
  journal={Nature Reviews Drug Discovery},
  year={2015},
  volume={14},
  pages={669-669}
}
  • Asher Mullard
  • Published 1 October 2015
  • Medicine
  • Nature Reviews Drug Discovery
resubmitted the drug in 2013, with data from a third pivotal trial, only to have it rejected again that year. Sprout resubmitted the drug this year with additional safety data. At an FDA advisory meeting in June, independent experts voted 18 to 6 to approve the drug with a risk evaluation and mitigation strategy (REMS). This vote and the approval a few months later led some critics to note that marketing tactics — including an effort by ‘Even The Score’, a Sprout-funded advocacy group, to… Expand
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