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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761262
Company: ABBVIE INC

Medication Guide

Products on BLA 761262

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SKYRIZI	RISANKIZUMAB-RZAA	600MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761262

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2022	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lblUpdated.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761262Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761262Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761105Orig1s027; 761262Orig1s008ltr.pdf
01/03/2024	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761262s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761262Orig1s005;761105Orig1s032ltr.pdf
09/23/2022	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761262Orig1s001ltr.pdf

Labels for BLA 761262

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf
01/03/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761262s005lbl.pdf
09/23/2022	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf
09/23/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf
06/16/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lblUpdated.pdf

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