Zydus Lifesciences (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 $249 million in the United States (IQVIA December. October. 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.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
