Zydus Lifesciences receives FDA approval for Amantadine extended-release capsules for Parkinson's disease treatment.

Zydus Lifesciences receives final US FDA approval for Amantadine extended-release capsules (68.5 mg) and tentative approval for 137 mg for Parkinson's disease treatment. The drug will be manufactured at their Ahmedabad SEZ-II facility and offers 180 days of exclusivity. This approval marks the company's 400th approval and brings its total Abbreviated New Drug Applications (ANDAs) filed since FY 2003-04 to 465.

August 28, 2024
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