Investor Area

Home / Investor Area / News / US FDA sets PDUFA date for SCENESSE®

US FDA sets PDUFA date for SCENESSE®

Melbourne, Australia 10 January 2019


Priority Review granted for innovative drug, PDUFA date 8 July 2019


 Executive summary

  • New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in accordance with 21 CFR 314.101(a)
  • Scientific exchange between FDA and CLINUVEL continues under Priority Review
  • FDA expects to communicate labelling and post-marketing commitments – if needed – by 8 April 2019
  • FDA does not plan to hold advisory committee meeting


Download PDF to read more