New Delhi: 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.
