Zydus Lifesciences has received tentative approval from the FDA to market its Amantadine Extended-Release Capsules in the United States. Amantadine is indicated for the treatment of dyskinesia (sudden uncontrolled movements) in patients with Parkinsons disease who are treated with levodopa therapy, with or without dopaminergic medicines. The pharmaceutical company said that the drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad Special Economic Zone, in India’s western state of Gujarat.
Amantadine Extended-Release Capsules had annual sales of $2.7 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
In other news, the company also won FDA approval to market Brivaracetam tablets. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. The drug will be manufactured at Ahmedabad SEZ, India. Brivaracetam Tablets had annual sales of $412 million in the United States according to IQVIA data.
Last updated: December 26th, 2025
