By: IPP Bureau
Last updated : December 18, 2023 5:12 pm
Lacosamide is indicated to treat partial-onset seizures
Zydus Lifesciences Limited 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.