Zydus Lifesciences Gains Approval for Parkinson's Medication from USFDA

Zydus Lifesciences has received approval from the USFDA to market Amantadine extended-release capsules for treating Parkinson's disease dyskinesia. The company's manufacturing facility in Ahmedabad SEZ - II will produce the medication. Zydus now holds 400 USFDA approvals and is eligible for 180 days of exclusivity for Amantadine extended-release capsules.

Zydus Lifesciences announced on Wednesday that it has secured approval from the US Food and Drug Administration (USFDA) to market a generic medication for Parkinson's disease.

The company has obtained approval to market Amantadine extended-release capsules (68.5 mg) and a tentative approval for Gocovri (137 mg) capsules, according to a statement from Zydus.

The medication is intended for the treatment of dyskinesia in Parkinson's disease patients and will be manufactured at the group's facility in Ahmedabad SEZ - II. This approval grants Zydus 180 days of exclusivity for the Amantadine extended-release capsules.

With this new approval, the Gujarat-based company now has 400 endorsements from the US health regulator.

(With inputs from agencies.)