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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213793
Company: RHYTHM

Products on NDA 213793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMCIVREE	SETMELANOTIDE ACETATE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213793Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213793Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2026	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213793Orig1s009ltr.pdf
08/21/2025	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213793Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213793Orig1s008ltr.pdf
12/20/2024	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213793s007lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213793Orig1s007Correctedltr.pdf
11/15/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213793s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213793Orig1s005ltr.pdf
06/16/2022	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213793Orig1s001ltr.pdf

Labels for NDA 213793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2026	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf
08/21/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213793Orig1s008lbl.pdf
08/21/2025	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213793Orig1s008lbl.pdf
08/21/2025	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213793Orig1s008lbl.pdf
12/20/2024	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213793s007lbledt.pdf
11/15/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213793s005lbl.pdf
06/16/2022	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213793s001lbl.pdf
11/25/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf

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