Aurobindo Pharma subsidiary receives FDA approval for Plerixafor Injection

Eugia Pharma Specialities Limited, a fully-owned subsidiary of India-based Aurobindo Pharma Limited, has received final approval from the US Food and Drug Administration (FDA).

This nod enables the pharmaceutical company to manufacture and market the Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), in a Single-Dose Vial. This product has been demonstrated to be bioequivalent and therapeutically equivalent to the Mozobil Injection, the reference listed drug (RLD) from Genzyme Corporation.

The launch of the approved product is scheduled for July in fiscal year 2024. According to IQVIA, this product commands an estimated market size of approximately $210 million for the twelve months ending in May 2023.

This latest development marks the 163rd Abbreviated New Drug Application (ANDA), inclusive of eight tentative approvals received, from Eugia Pharma Speciality Group (EPSG) facilities. These facilities are instrumental in manufacturing both oral and sterile specialty products.

The FDA-approved Plerixafor injection is indicated for use in combination with the granulocyte-colony stimulating factor (G-CSF). Its purpose is to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection. Subsequently, these collected cells are utilized for autologous transplantation in patients diagnosed with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM). This major stride in medical advancement will significantly aid patients battling these serious medical conditions.