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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761107
Company: NOVIMMUNE S.A.

Medication Guide

Products on BLA 761107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GAMIFANT	EMAPALUMAB-LZSG	10MG/2ML	INJECTABLE;INJECTION	Prescription	None	No	No
GAMIFANT	EMAPALUMAB-LZSG	50MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No
GAMIFANT	EMAPALUMAB-LZSG	100MG/20ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761107Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761107Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2026	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761107s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761107Orig1s0s22ltr.pdf
06/27/2025	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761107s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761107Orig1s018ltr.pdf
06/26/2020	SUPPL-4	Supplement		Label is not available on this site.

Labels for BLA 761107

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2026	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761107s022lbl.pdf
03/17/2026	SUPPL-22	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761107s022lbl.pdf
06/27/2025	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761107s018lbl.pdf
11/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf

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