Zydus receives final approval from the USFDA for Lacosamide Tablets

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 manufacture and market Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Vimpat® Tablets).

Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).

Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg had annual sales of USD 249 mn in the United States (IQVIA Dec. Oct. 2023).

The group now has 384 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 646.20 as compared to the previous close of Rs. 643.50. The total number of shares traded during the day was 16151 in over 1041 trades.

The stock hit an intraday high of Rs. 651.05 and intraday low of 642.45. The net turnover during the day was Rs. 10439238.00.

(*as of 30th September 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences FinalApproval USFDA LacosamideTablets INE010B01027