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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761032
Company: VALEANT LUXEMBOURG

Medication Guide

REMS

Products on BLA 761032

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILIQ	BRODALUMAB	210MG/1.5ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761032

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2024	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761032Orig1s016ltr.pdf
08/12/2024	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761032Orig1s014ltr.pdf
07/19/2023	SUPPL-11	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761032Orig1s011ltr.pdf
06/14/2022	SUPPL-10	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761032Orig1s010ltr.pdf
01/22/2021	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761032Orig1s008ltr.pdf
10/09/2018	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761032Orig1s005ltr.pdf
01/26/2018	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761032Orig1s004ltr.pdf
06/08/2017	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761032Orig1s001ltr.pdf

Labels for BLA 761032

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s014lbl.pdf
08/12/2024	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s014lbl.pdf
07/02/2024	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s016lbl.pdf
07/02/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761032s016lbl.pdf
02/15/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf

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