CMS TransmittalDermatology

FDA Approval: SKYRIZI (RISANKIZUMAB-RZAA) — Type 3 - New Dosage Form

FDA-BLA761262

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA761262
Published
June 18, 2026
Effective date
June 16, 2022
MAC region
National

Summary

SKYRIZI (risankizumab-rzaa) is an injectable drug approved for use under Medicare Part B, likely leading to the assignment of a new J-code for billing purposes. As an orphan drug in the interleukin-23

New injectable drug SKYRIZI approved with possible J-code.

Affected specialty

Dermatology alerts →

Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lblUpdated.pdf

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