Good morning

Eugia Pharma Receives USFDA Approval for Azacitidine for Injection, 100 mg Single-Dose Vial

Published: January 03, 2023

Eugia US is pleased to announce that the company has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg Single-Dose Vial.

Indications for this product include:

  • Indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

Refer to package insert for full prescribing information.