Aurobindo Pharma said that its wholly owned subsidiary Eugia Pharma Specialities has received US Food & Drug Administration (US FDA) approval to manufacture and market Azacitidine for injection.
Azacitidine for injection would be the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vidaza for injection of Bristol-Myers Squibb Company.
Azacitidine is indicated for the treatment of adult patients with the French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes. The subtypes include refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T) and chronic myelomonocytic leukemia (CMMoL).
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, Aurobindo Pharma said in a statement.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
The scrip rose 0.53% to currently trade at Rs 443.55 on the BSE.
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