FDA Clarifies SCENESSE® PDUFA Date

CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) has notified the company that the Prescription Drug User Fee Act (PDUFA) goal date for review of the submission of the SCENESSE^® (afamelanotide 16mg) scientific dossier had been miscommunicated by the Agency and now has been confirmed for 8 October 2019, instead of the earlier reported 6 October.