Zydus receives USFDA tentative approval for Edaravone Injection

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture and market Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single-Dose Vial, (RLD: RADICAVA).

Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).

Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), had annual sales of USD 19 mn. in the United States (IQVIA MAT Jan-24).

Powered by Capital Market - Live News