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Onureg FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved September 1, 2020)
Brand name: Onureg
Generic name: azacitidine
Dosage form: Tablets
Company: Bristol-Myers Squibb Company
Treatment for: Acute Myeloid Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

Development timeline for Onureg

Sep  1, 2020Approval FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
May  1, 2020U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
Sep 12, 2019Celgene Announces Phase 3 QUAZAR® AML-001 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Met Primary and Key Secondary Endpoints

Further information

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