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Clinuvel Pharmaceuticals Announces US FDA Sets PDUFA Date for SCENESSE

10 Jan 2019  |  10:35:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: US FDA sets PDUFA date for SCENESSE

Clinuvel Pharmaceuticals announced that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act (PDUFA) date of 8 July 2019. A New Drug Application (NDA) for the use of SCENESSE (afamelanotide 16mg) in the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP) had been submitted under Section 505b of the Federal Food, Drug, and Cosmetic Act. PDUFA establishes target dates for review of NDAs by the FDA. SCENESSE will be evaluated under PDUFA VI, reauthorised by the Food and Drug Administration Reauthorization Act of 2017, as a Priority Review.

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