Onureg

Treats acute myeloid leukemia. NDA 214120, held by Bristol. Azacitidine.

As of Nov 14, 2026, NDA 214120 (Onureg), held by Bristol, was first approved by FDA on Sep 1, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 1, 2020
Review: Priority
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Apr 9, 2026	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 1, 2020	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Onureg200MG · tablet;oral	Azacitidine	RxReference drug
Onureg300MG · tablet;oral	Azacitidine	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Apr 9, 2026	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2021	Supplement 1Manufacturing	Approved	Letter Label
Sep 1, 2020	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 214120
Drugs@FDA: Overview at FDA
Company: Bristol Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters