SCENESSE
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SCENESSE safely and effectively. See full prescribing information for SCENESSE. SCENESSE® (afamelanotide) implant, for subcutaneous use. Initial U.S. Approval: 2019
Approved
Approval ID
94f53286-11dd-7fbb-e053-2a95a90a7c48
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
CLINUVEL INC.
DUNS: 937954977
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
afamelanotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73372-0116
Application NumberNDA210797
Product Classification
M
Marketing Category
C73594
G
Generic Name
afamelanotide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 16, 2023
FDA Product Classification
INGREDIENTS (1)
AFAMELANOTIDEActive
Quantity: 16 mg in 16 mg
Code: QW68W3J66U
Classification: ACTIB