Aurobindo Pharma arm bags USFDA nod for Plerixafor Injection
Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.
Hyderabad: Drugmaker, Aurobindo Pharma Limited has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mozobil Injection, 24 mg/1.2 mL (20 mg/mL) of Genzyme Corporation.
The product is being launched in July FY24.
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023, according to IQVIA. This is the 163rd ANDA (including 8 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
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Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM). Non-Hodgkin lymphoma is a group of blood cancers that includes all types of lymphomas except Hodgkin lymphomas. Multiple myeloma is a cancer of plasma cells, a type of white blood cell that normally produces antibodies.
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