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Generic injectable-focused firm Gland Pharma has received U.S Food and Drug Administration (U.S. FDA) approval for two injections.
In separate announcements on Tuesday, the company said it has received U.S. FDA approval for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), single-dose vial. Bioequivalent and therapeutically equivalent to the reference listed drug Mozobil (plerixafor) injection of Genzyme Corporation, a Sanofi company, the approved product is a hematopoietic stem cell mobiliser.
It is indicated in combination with filgrastim to mobilise hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma. The product had U.S. sales of approximately $152 million for the 12 months ending January 2024, the company said citing IQVIA numbers.
Gland Pharma expects to launch the product through its marketing partner in FY25.
The company has also received U.S. FDA approval for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), single-dose bags.
The product is bioequivalent and therapeutically equivalent to the reference listed drug Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation. It is used to treat amyotrophic lateral sclerosis (ALS), a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken, Gland Pharma said.
It expects to launch this product too through its marketing partner in FY25. The product had U.S. sales of approximately $19 million for the twelve months ending January 2024, Gland Pharma said citing IQVIA numbers.
