2019 Announcements
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