Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg

Also received tentative approval for 137 mg

Zydus Lifesciences Limited 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, India.

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.