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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761029
Company: BIOGEN

Medication Guide

Summary Review

Products on BLA 761029

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINBRYTA	DACLIZUMAB	150MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2017	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf
11/01/2017	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s005ltr.pdf
08/28/2017	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s002,s007ltr.pdf
05/26/2017	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s001ltr.pdf

Labels for BLA 761029

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf
08/28/2017	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf
08/28/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf
05/26/2017	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf
05/27/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf

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