Aurobindo Pharma Ltd on Tuesday said its wholly-owned arm Eugia Pharma Specialities has received a final approval from the US health regulator for its generic version of Plerixafor injection indicated for patients with certain types of cancer to prepare them for stem cell transplant.
The approval granted by the US Food & Drug Administration (USFDA) is to manufacture and market Plerixafor Injection of strengths 24 mg/1.2 mL (20 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing.
It is bioequivalent and therapeutically equivalent to the reference listed drug, Mozobil injection, 24 mg/1.2 mL (20 mg/mL) of Genzyme Corporation.
Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise 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), the company said.
The product is being launched this month, Aurobindo Pharma said.
The approved product has an estimated market size of around USD 210 million for the 12 months ending May 2023, it said citing IQVIA data.
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