Zydus Lifesciences bags USFDA tentative nod for Edaravone Injection to treat amyotrophic lateral sclerosis

Ahmedabad: Zydus Lifesciences Limited has announced that the Company 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).

Amyotrophic lateral sclerosis (ALS) is a rare and terminal neurodegenerative disease that results in the progressive loss of motor neurons. Motor neurons control voluntary muscles. ALS is the most common form of the motor neuron diseases. Early symptoms of ALS include muscle twitches, stiff muscles, muscle wasting, and gradual increasing weakness.

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). The group now has 390 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences wins USFDA nod for Chlorpromazine Hydrochloride Injection for certain mental disorders

Medical Dialogues team had earlier reported that Zydus had received permission from CDSCO, India, to initiate the Phase II clinical study of NLRP3 inhibitor “ZYIL1” in patients with Amyotrophic Lateral Sclerosis (ALS).

Read also: Zydus Lifesciences gets CDSCO nod to begin Phase II clinical trial of ZYIL1 in Amyotrophic Lateral Sclerosis patients