Zydus Lifesciences receives US FDA approval for Parkinson’s drug

Zydus Lifesciences Ltd. announced on Wednesday that the company has received approval from the U.S. Food and Drug Administration to market a generic drug for the treatment of Parkinson's disease.

The company has received approval from the US FDA to market extended-release amantadine capsules (68.5 mg) as well as provisional approval for Gocovri capsules (137 mg), the pharmaceutical company said in a statement.

Amantadine extended-release capsules are intended for the treatment of dyskinesia in Parkinson's patients, the company said in a statement.

The drug will be manufactured at the group's manufacturing facility in Ahmedabad SEZ-III, Zydus Lifesciences said.

With this approval, Zydus is entitled to 180 days of exclusivity for extended-release amantadine capsules (68.5 mg), it said.

The Gujarat-based company says it now has over 400 approvals from the US FDA.

Shares of Zydus Lifesciences closed 2.17% higher at Rs 1,138.05 per share, compared to a 0.09% rise in the BSE Sensex.

(With inputs from PTI)