Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product).
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a Sanofi Company.
The Product is a hematopoietic stem cell mobilizer indicated in combination with filgrastim 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.
The Company expects to launch this Product through its marketing partner within FY25. According to IQVIA, the product had US sales of approximately USD 152 million for the twelve months ending January 2024.
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