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🏅 FDA Orphan Designation

Azacitidine

AZACITIDINE FOR

Manufacturer: Pilnova Pharma Inc

Indicated for:
Chronic myelomonocytic leukemiaAcquired idiopathic sideroblastic anemiaMyelodysplastic neoplasm with increased blastsMyelodysplastic neoplasm with low blasts

FDA-Approved Indications (4)

indicated for the treatment of adult patients with chronic myelomonocytic leukemia (CMMoL)

Population: adults

indicated for the treatment of adult patients with refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions)

Population: adults

indicated for the treatment of adult patients with refractory anemia with excess blasts (RAEB)

Population: adults

indicated for the treatment of adult patients with refractory anemia (RA)

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor 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). ( 1.1 ) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (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). Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection). However, due to Celgene Corporation's marketing exclusivity rights, this drug product is not labeled with that information.

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AZACITIDINE
Pilnova Pharma Inc
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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.