Zydus gets final approval from USFDA for Lacosamide injection

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to market its generic Lacosamide injection, which is used to treat partial-onset seizures.

The approval granted by the US Food and Drug Administration (USFDA) is for Lacosamide injection of strength 200 mg/20 ml (10 mg/ml) single-dose vials, the company said in a regulatory filing.

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat, it added. Lacosamide injection is used to treat partial-onset seizures. It is also used with other medicines to treat primary generalised tonic-clonic seizures. It acts on the Central Nervous System (CNS) to reduce the number and severity of seizures, the company said. Citing IQVIA MAT May 22 data, Zydus said Lacosamide injection has a market size of USD 50 million.

The group now has 316 approvals and has so far filed over 420 abbreviated new drug applications since the commencement of the filing process in FY 2003-04, it said.