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FDA NDA · NDA213793

IMCIVREE

setmelanotide

Sponsor: RHYTHM

APPLICATION
NDA213793
TYPE
NDA
ORIGINAL APPROVAL
2020-11-25
LATEST ACTION
2026-03-19
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

IMCIVREE · ReferencePrescription
SETMELANOTIDE ACETATE EQ 10MG BASE/ML (EQ 10MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-03-19Efficacy · Supplement 9 · priority — Letter ↗AP
2025-08-21Labeling · Supplement 8 · standard — Label ↗AP
2024-12-20Efficacy · Supplement 7 · priority — Label ↗AP
2023-11-15Labeling · Supplement 5 · standard — Letter ↗AP
2022-06-16Efficacy · Supplement 1 · priority — Label ↗AP
2020-11-25Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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