Zydus Gets USFDA Nod for Amantadine ER Capsules, 68.5 mg Final, 137 mg Tentative Approval
Eligible for 180 days of generic drug exclusivity for Amantadine extended-release capsules, 68.5 mg
BILKULONLINE
Ahmedabad, Aug 28: Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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 extended-release 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.
(*as of 30th June 2024)
