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VORANIGO

vorasidenib · Tablet, Film Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
VORANIGO
Generic name
vorasidenib
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Servier Pharmaceuticals LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Vorasidenib 10 mg/1 — —
Vorasidenib 40 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 3A Inducers [MoA] MoA All 37 members
Isocitrate Dehydrogenase 1 Inhibitor [EPC] EPC 1 member — no class page
Isocitrate Dehydrogenase 1 Inhibitors [MoA] MoA 1 member — no class page
Isocitrate Dehydrogenase 2 Inhibitor [EPC] EPC 2 members — no class page
Isocitrate Dehydrogenase 2 Inhibitors [MoA] MoA 2 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218784
Application type
NDA · New Drug Application
Approval date
August 6, 2024
Sponsor
SERVIER
Products on application
2
Submissions recorded
3
Products approved under application 218784.
Product Trade name Form Strength Ingredient Status TE Flags
218784-001 VORANIGO TABLET VORASIDENIB Prescription — RLD
218784-002 VORANIGO TABLET VORASIDENIB Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
12433895 July 11, 2034 001 No U-4286 October 22, 2025
10172864 July 11, 2034 001 Yes August 27, 2024
9579324 July 11, 2034 001 Yes August 27, 2024
12433895 July 11, 2034 002 No U-4286 October 22, 2025
9579324 July 11, 2034 002 Yes August 27, 2024
10172864 July 11, 2034 002 Yes August 27, 2024
11844758 December 4, 2035 001 No U-3977 August 27, 2024
11844758 December 4, 2035 002 No U-3977 August 27, 2024
11345677 January 16, 2039 001 Yes U-3978 August 27, 2024
11345677 January 16, 2039 002 Yes U-3978 August 27, 2024
Regulatory exclusivity periods.
Code Expires Product
NCE August 6, 2029 001
NCE August 6, 2029 002
ODE-491 August 6, 2031 001
ODE-491 August 6, 2031 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 218784.
Type No. Action Status Date Review
Supplement 4 Labeling Approved June 10, 2026 Standard
Supplement 2 Labeling Approved April 8, 2025 Standard
Original application 1 Type 1 - New Molecular Entity Approved August 6, 2024 Priority

Review documents

  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · June 11, 2026
  • 0 · Supplement · April 9, 2025
  • 0 · Supplement · April 8, 2025
  • 0 · Original application · August 28, 2024
  • 0 · Original application · August 8, 2024
  • 0 · Original application · August 8, 2024

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72694-728-40 72694-728 Servier Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE August 7, 2024
72694-879-10 72694-879 Servier Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE August 7, 2024
72694-728 72694-728 Servier Pharmaceuticals LLC — August 7, 2024
72694-879 72694-879 Servier Pharmaceuticals LLC — August 7, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 10 sections on this page.