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The regulatory picture is unusual and worth stating plainly: the afamelanotide molecule is FDA-approved but only as SCENESSE, a 16 mg controlled-release bioresorbable implant placed by a trained clinician to reduce phototoxic pain in adults with erythropoietic protoporphyria (EPP), a rare light-sensitivity disorder [1]
Cavigelli SA, McClintock MK
Journal of Investigative Dermatology, 113(3), 364-368
6(4): 31722 Hokland BM, Bremer J
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