General MedicationsSUBCUTANEOUSStandard
IMCIVREE
SETMELANOTIDE ACETATE
Standard Dose
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview IMCIVREE is listed in Drugs@FDA under application 213793 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient SETMELANOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 10MG BASE/ML (EQ 10MG BASE/ML) Sponsor RHYTHM Submission history Latest submission status date: 2026-03-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview IMCIVREE is listed in Drugs@FDA under application 213793 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient SETMELANOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 10MG BASE/ML (EQ 10MG BASE/ML) Sponsor RHYTHM Submission history Latest submission status date: 2026-03-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.