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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761183
Company: PROVENTION BIO INC

Medication Guide

Products on BLA 761183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TZIELD	TEPLIZUMAB-MZWV	2MG/2ML(1MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2022	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761183Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761183Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2026	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761183s010,014ltr.pdf
04/20/2026	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761183Orig1s013ltr.pdf
06/12/2026	SUPPL-10	Supplement	Label (PDF) Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761183s010,014ltr.pdf

Labels for BLA 761183

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2026	SUPPL-14	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf
06/12/2026	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf
06/12/2026	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s010lbls014lbl.pdf
04/20/2026	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s013lbl.pdf
11/17/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183Orig1s000lbl.pdf

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