Drug firm Zydus Cadila Tuesday said it has received a final nod from the US health regulator to market generic Clobazam tablets used for the treatment of seizures caused by a pediatric epilepsy syndrome.
The company has received the final approval from the United States Food and Drug Administration (USFDA) to market Clobazam tablets in the strengths of 10 mg and 20 mg, in the American market, Zydus Cadila said in a statement.
The product is a generic version of Onfi tablets, it added.
The tablets “will be manufactured at the group’s formulations manufacturing facility at Special Economic Zone (SEZ), Ahmedabad,” Zydus Cadila said.
Clobazam is used in combination with other medications to treat seizures caused by a pediatric epilepsy syndrome (Lennox-Gastaut syndrome) that also causes developmental and behavioural problems, it added.
The group now has 224 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
Shares of Cadila Healthcare, the listed entity of the group, were today trading at Rs 369.80 per scrip on BSE, down 0.98 per cent from its previous close.