Posted by Michael Wonder on 11 Jan 2019
US FDA sets PDUFA date for Scenesse
10 January 2019 - FDA does not plan to hold advisory committee meeting.
Clinuvel today announced that the US FDA Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act date of 8 July 2019. A new drug application for the use of Scenesse (afamelanotide 16 mg) in the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria had been submitted under Section 505b of the Federal Food, Drug, and Cosmetic Act.
