Gland Pharma secures USFDA approval for Edaravone and Plerixafor injections

Gland Pharma Ltd’s shares were up after the company received approval from the United States Food and Drug Administration (USFDA) for two products, Edaravone Injection and Plerixafor Injection.  

Edaravone Injection, available in 30 mg/100 mL and 60 mg/100 mL Single-Dose Bags, 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. While Plerixafor Injection, 24 mg/1.2 mL Single-Dose Vial, is a hematopoietic stem cell mobilizer for patients with non-Hodgkin’s lymphoma or multiple myeloma. The product helps move certain cells in the blood to make it easier to collect and use them for transplant in patients with specific types of cancer.

• Also read: Gland Pharma receives approval for cetrorelix acetate for injection

The company reported that both products are bioequivalent and therapeutically equivalent to their respective reference listed drugs (RLDs). Gland Pharma anticipates launching these products through its marketing partner within the fiscal year 2025. According to IQVIA, Edaravone had US sales of approximately $19 million and Plerixafor had US sales of approximately $152 million for the twelve months ending January 2024.

The shares were up by 0.42 per cent to ₹1,712.35 at 2.46 pm on the BSE.  

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