Zydus Lifesciences Gets US FDA Nod For Parkinson's Disease Drug
The Gujarat-based group said it now has 400 approvals from the US FDA.
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Zydus Lifesciences Ltd. announced on Wednesday that the company has received approval from the United States Food and Drug Administration to market a generic medication to treat Parkinson's disease.
The company has received approval from the US FDA to market Amantadine extended-release capsules (68.5 mg) and tentative approval for Gocovri (137 mg) capsules, the drug firm said in a statement.
Amantadine extended-release capsules are designed to treat dyskinesia in Parkinson's disease patients, as per the company's statement.
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ-III, Zydus Lifesciences said.
This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules (68.5 mg), it added.
The Gujarat-based group said it now has 400 approvals from the US FDA.
Shares of Zydus Lifesciences closed 2.17% higher at Rs 1,138.05 per share, as compared to a 0.09% advance in the BSE Sensex.
(With inputs from PTI)
