Gland Pharma receives USFDA approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis (ALS)

 Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) 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 (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation.

 The Product 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. 

The Company expects to launch this Product through its marketing partner within FY25. According to IQVIA, the product had US sales of approximately USD 19 million for the twelve months ending January 2024.