Federal Register NoticeOncology

FDA Approval: VORANIGO (VORASIDENIB) — Type 1 - New Molecular Entity

FDA-NDA218784

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA218784
Published
June 13, 2026
Effective date
August 6, 2024
MAC region
National

Summary

As Voranigo (vorasidenib) is an oral tablet, it will be billed under the Part D pathway. Billing teams should confirm details against the FDA label for any updates related to the drug's billing specif

Voranigo (vorasidenib) approved as an oral therapy for billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf

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