Aurobindo Pharma arm Eugia Pharma gets USFDA nod for Azacitidine injection by admin- Wednesday, January 4th, 2023 05:13:46 PM
Aurobindo Pharma announced that its absolutely owned subsidiary organisation, Eugia Pharma Specialities Ltd, has obtained a final approval from the USA Food & Drug Administration (USFDA) to manufacture and marketplace Azacitidine for Injection, one hundred mg Single-Dose Vial. Azacitidine for Injection, 100 mg Single-Dose Vial, to be bioequivalent and therapeutically equal to the Reference Listed Drug (RLD), Vidaza for Injection, 100 mg Single-Dose Vial, of Bristol-Myers Squibb Company. The product is anticipated to be released by way of this month. The approved product has an estimated market length of round US$ forty six million for the twelve months ending November 2022, according to IQVIA.
This is the 153rd ANDA (inclusive of 10 tentative approvals obtained) out of Eugia Pharma Speciality Group (EPSG) centers, production both oral and sterile area of expertise merchandise.
Indicated for the treatment of person sufferers with the following FAB myelodysplastic syndrome (MDS) subtypes:
Refractory Anemia (RA) or Refractory Anemia with Ringed Sideroblasts (RARS) (if followed via neutropenia or thrombocytopenia or requiring transfusions),
Refractory Anemia with Excess Blasts (RAEB),
Refractory Anemia with Excess Blasts in Transformation (RAEB-T),
Chronic Myelomonocytic Leukemia (CMMoL).