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

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 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 1113.85 as compared to the previous close of Rs. 1108.45. The total number of shares traded during the day was 133824 in over 6306 trades.

The stock hit an intraday high of Rs. 1134.50 and intraday low of 1108.65. The net turnover during the day was Rs. 149612378.00.

(*as of 30th June 2024)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 FinalApproval USFDA Amantadine ExtendedReleaseCapsules