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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761105
Company: ABBVIE INC

Medication Guide

Products on BLA 761105

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SKYRIZI	RISANKIZUMAB-RZAA	75MG/0.83ML	INJECTABLE;INJECTION	Prescription	None	No	No
SKYRIZI	RISANKIZUMAB-RZAA	150MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761105

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2019	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761105s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2024	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761262Orig1s005;761105Orig1s032ltr.pdf
03/04/2024	SUPPL-27	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
09/23/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s018ltr.pdf
06/16/2022	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s016ltr.pdf
01/21/2022	SUPPL-14	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761105Orig1s014.pdf
04/26/2021	SUPPL-10	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761105Orig1s009,s010.pdf
04/26/2021	SUPPL-9	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761105Orig1s009,s010.pdf
03/20/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761105Orig1s005ltr.pdf

Labels for BLA 761105

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf
01/03/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s032lbl.pdf
09/23/2022	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf
06/16/2022	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf
01/21/2022	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf
04/26/2021	SUPPL-10	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf
04/26/2021	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf
03/20/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf
04/23/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf

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