Aurobindo Pharma arm gets USFDA nod for Azacitidine for Injection to treat myelodysplastic syndrome
The product is indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes.;
Hyderabad: Aurobindo Pharma Limited today announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azacitidine for Injection, 100 mg Single-Dose Vial.
Azacitidine for Injection, 100 mg Single-Dose Vial, to be bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vidaza for Injection, 100 mg Single-Dose Vial, of Bristol-Myers Squibb Company.
The product is indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes:
o Refractory Anemia (RA) or Refractory Anemia with Ringed Sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions),
o Refractory Anemia with Excess Blasts (RAEB),
o Refractory Anemia with Excess Blasts in Transformation (RAEB-T),
o Chronic Myelomonocytic Leukemia (CMMoL).
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