Zydus receives tentative approval from the USFDA for Amantadine Extended-Release Capsules

Following the United States Food and Drug Administration’s (USFDA) provisional permission for the sale of Amantadine extended-release capsules, Zydus Lifesciences increased 2.39% to Rs 419.10 on the news. Amantadine is used to treat dyskinesia (sudden uncontrollable movements) in Parkinson’s disease patients receiving levodopa therapy, either with or without dopaminergic drugs.

The medicine will be produced, according to the pharmaceutical business, at the group’s formulation manufacturing plant in Ahmedabad SEZ, India. Amantadine Extended-Release Capsules had yearly sales in the United States of $2.7 million, based on IQVIA MAT data from August 2022. Since the filing procedure began in FY 2003-04, the group has received 325 approvals and has submitted over 428 ANDAs.

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