Eugia Pharma Gets USFDA Nod For Generic Anemia Drug
Eugia Pharma Specialities a wholly owned subsidiary of Aurobindo Pharma has received a final approval from the US Food and Drug Administration (USFDA) to manufacture and market Azacitidine Injection of 100 mg Single-Dose Vials, the company said in a regulatory filing on Wednesday.
Azacitidine drug for Injection is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vidaza Injection, 100 mg Single-Dose Vial, of Bristol-Myers Squibb Company.
The product is expected to be launched by this month. The approved product has an estimated market size of around US$ 46 million for the twelve months ending November 2022, according to IQVIA.
This is the 153rd ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The approved drug is indicated for the treatment of adult patients with Refractory Anemia or Refractory Anemia with Ringed Sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), Refractory Anemia with Excess Blasts, Refractory Anemia with Excess Blasts in Transformation and Chronic Myelomonocytic Leukemia.
