2018 Announcements

US FDA Update

05 September 2018

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the US Food and Drug Administration (FDA) has issued a request for further documentation to support CLINUVEL’s new drug application (NDA) for SCENESSE® (afamelanotide 16mg). This additional information covers product manufacturing information and details from the European post-authorisation use of SCENESSE®.

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