Seizure drug: Zydus Lifesciences gets USFDA approval for Lacosamide tablets

Ahmedabad: 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.

Read also: Zydus Lifesciences bags USFDA nod for HIV-1 drug Darunavir

Medical dialogues team had earlier reported that the Company had received final approval from the USFDA for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg (USRLD: Trileptal Tablets, 150 mg, 300 mg, and 600 mg).

Read also: Zydus Lifesciences wins USFDA approval for Oxcarbazepine tablets to treat seizure disorders