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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

 

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