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BUSINESS

Aurobindo Pharma Arm Gets USFDA Approval for Plerixafor Injection

The USFDA inspected Aurobindo Pharma's Unit-II API manufacturing facility from 23rd to 27th September, 2024.

Eugia Pharma, a wholly-owned arm of Aurobindo Pharma Ltd, on July 25 Thursday said it had received final approval from the US Food and Drug Administration (USFDA) 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 USFDA to manufacture and market Plerixafor Injection of strengths 24 mg/1.2 mL (20 mg/mL), single-dose vial, Aurobindo Pharma said.

The injection is bioequivalent and therapeutically equivalent to the 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 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), the company said.

The product is scheduled to be launched this month, Aurobindo Pharma said.

The approved product has an estimated market size of around $210 million for the 12 months ending May 2023.

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