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CLINUVEL PHARMACEUTICALS LTD announced this week that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a new review goal date of October 6, 2019 to provide more time for a full review of the submission of the SCENESSE® (afamelanotide 16mg). The original date was July 8, 2016 granted under PRIORTY REVIEW – a designation that offers a 6-month review period, rather than a 10-month standard review.
