Last Updated on December 31, 2023 by The Health Master
Ahmedabad: Zydus Lifesciences Limited’s US subsidiary, Zydus Pharmaceuticals (USA) Inc., has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine extended-release capsules (USP 68.5 mg and 137 mg).
Amantadine is indicated for the treatment of dyskinesia in patients with Parkinson’s disease who are treated with levodopa therapy, with or without dopaminergic medicines.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Amantadine extended-release capsules had annual sales of USD 2.7 mn in the United States according to IQVIA MAT Aug 2022.
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