For a history of phototoxic reactions from erythropoietic protoporphyria (EPP). NDA 210797, held by Clivunel Inc. Afamelanotide.
As of Nov 13, 2026, NDA 210797 (Scenesse), held by Clivunel Inc, was first approved by FDA on Oct 8, 2019, with 1 approved supplement and 0 published complete response letters.
SCENESSE is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Scenesse16MG · implant;subcutaneous | Afamelanotide | RxReference drug |
| Aug 12, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Oct 8, 2019 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
