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USFDA approves Gland Pharma Plerixafor Injection
Hyderabad: Generic injectable-focused pharmaceutical company, Gland Pharma Limited, 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,...
Hyderabad: Generic injectable-focused pharmaceutical company, Gland Pharma Limited, 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.
Read also: Gland Pharma appoints Satnam Singh Loomba as COO, Senior Management Personnel
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751