Drug firm Zydus Cadila on Monday said it has has received a tentative nod from the US health regulator for marketing generic Lacosamide tablets, used for prevention and treatment of seizures, in the American market.
The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market generic Lacosamide tablets in the strengths of 50 mg, 100 mg, 150 mg and 200 mg, Zydus Cadila said in a statement.
The product is a generic version of Vimpat tablets, it added.
“The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad,” Zydus Cadila said.
Lacosamide is an anti-convulsant or anti-epileptic drug, used to prevent and control seizures. It works by reducing the spread of seizure activity in the brain, it added.
The group now has 261 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.