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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125390
Company: AMRYT

Medication Guide

REMS

Summary Review

Products on BLA 125390

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYALEPT	METRELEPTIN	11.3MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125390

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2014	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2023	SUPPL-25	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125390Orig1s025ltr.pdf
02/28/2022	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125390s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125390Orig1s024ltr.pdf
06/09/2021	SUPPL-23	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125390Orig1s023ltr.pdf
07/13/2020	SUPPL-21	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125390Orig1s021ltr.pdf
12/13/2019	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125390s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125390Orig1s017ltr.pdf
05/15/2020	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125390s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125390Orig1s016ltr.pdf
12/21/2018	SUPPL-14	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125390Orig1s014Ltr.pdf
12/11/2017	SUPPL-12	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125390Orig1s012ltr.pdf
09/22/2015	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s010ltr.pdf
08/27/2015	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s006ltr.pdf
06/30/2014	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s004ltr.pdf

Labels for BLA 125390

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125390s024lbl.pdf
05/15/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125390s016lbl.pdf
12/13/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125390s017lbl.pdf
12/13/2019	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125390s017lbl.pdf
09/22/2015	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf
08/27/2015	SUPPL-6	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
06/30/2014	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf
02/24/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf

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