Zydus Lifesciences gets USFDA nod for generic medication

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market a generic medication to treat Parkinson's disease. The company has received approval from the US Food and Drug Administration (USFDA) 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 indicated for the treatment of dyskinesia in patients with Parkinson's disease.

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, 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 USFDA.