Aurobindo Pharma subsidiary gets USFDA approval for Azacitidine injection

4 Jan 2023 , 02:50 AM

Aurobindo Pharma Limited announced to the exchanges on Wednesday that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA).

As per the filing, the USFDA approval is 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 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.

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),
• Chronic Myelomonocytic Leukemia (CMMoL).

At around 2:43 PM, Aurobindo Pharma was trading at Rs440.60 per share lower by 0.16% on the BSE.

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