Aurobindo Pharma subsidiary Eugia Pharma Specialities Ltd. (Eugia) obtained a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Aurobindo’s product can be to be had in ready-to-use (RTU) injection practise. The product shall be launched within the US market in the near term and may be manufactured in Eugia’s production facility in India.
Aurobindo’s Cyclophosphamide Injection is indicated for
Malignant lymphomas
Multiple myeloma
Leukemias
Mycosis fungoides (superior disease)
Neuroblastoma (disseminated sickness)
Adenocarcinoma of the ovary
Retinoblastoma
Carcinoma of the breast
The accredited product has an addressable marketplace length of US$ a hundred and seventy million for the three hundred and sixty five days ending June 2021 in step with IQVIA.
This is the nineteenth product to be accredited for Eugia. Aurobindo now has a total of 482 ANDA approvals from USFDA.
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