Zydus gains final USFDA approval for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg (USRLD: Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg).

Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II.

This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extendedrelease capsules, 68.5 mg. The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04.