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.
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).
Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D.