← FDA DRUG APPROVALS

FDA BLA · BLA761262

SKYRIZI

risankizumab-rzaa

Sponsor: ABBVIE INC

APPLICATION
BLA761262
TYPE
BLA
ORIGINAL APPROVAL
2022-06-16
LATEST ACTION
2026-06-26
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SKYRIZIPrescription
RISANKIZUMAB-RZAA 600MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2026-06-26Labeling · Supplement 16 · standard — Letter ↗AP
2026-06-12Labeling · Supplement 15 · standard — Label ↗AP
2026-03-18Labeling · Supplement 17 · standard — Letter ↗AP
2026-03-06Labeling · Supplement 14 · standard — Letter ↗AP
2025-09-03Efficacy · Supplement 11 · standard — Letter ↗AP
2025-05-07Labeling · Supplement 10 · standard — Letter ↗AP
2024-06-18Efficacy · Supplement 7 · standard — Letter ↗AP
2024-03-04Labeling · Supplement 8 · standard — Letter ↗AP
2024-01-03Labeling · Supplement 5 · standard — Label ↗AP
2022-09-23Labeling · Supplement 1 · standard — Letter ↗AP
2022-06-16Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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