Gland Pharma Limited, a generic injectable-focused pharmaceutical company, 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.