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FDA BLA · BLA761105

SKYRIZI

risankizumab-rzaa

Sponsor: ABBVIE INC

APPLICATION
BLA761105
TYPE
BLA
ORIGINAL APPROVAL
2019-04-23
LATEST ACTION
2026-06-26
ROUTE
SUBCUTANEOUS, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SKYRIZIPrescription
RISANKIZUMAB-RZAA 150MG/ML · INJECTABLE · INJECTION
SKYRIZIPrescription
RISANKIZUMAB-RZAA 75MG/0.83ML · INJECTABLE · INJECTION

Approval history

2026-06-26Efficacy · Supplement 45 · standard — Letter ↗AP
2026-06-12Efficacy · Supplement 44 · standard — Letter ↗AP
2026-03-18Labeling · Supplement 47 · standard — Letter ↗AP
2026-03-06Efficacy · Supplement 42 · standard — Letter ↗AP
2025-09-03Efficacy · Supplement 39 · standard — Letter ↗AP
2025-05-07Labeling · Supplement 38 · standard — Letter ↗AP
2024-06-18Efficacy · Supplement 29 · standard — Letter ↗AP
2024-03-04Labeling · Supplement 27 · standard — Letter ↗AP
2024-01-03Labeling · Supplement 32 · standard — Label ↗AP
2022-09-23Efficacy · Supplement 18 · standard — Letter ↗AP
2022-06-16Efficacy · Supplement 16 · priority — Letter ↗AP
2022-01-21Efficacy · Supplement 14 · standard — Letter ↗AP
2021-04-26Efficacy · Supplement 9 · standard — Letter ↗AP
2021-04-26Efficacy · Supplement 10 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 5 · standard — Label ↗AP
2019-04-23Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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