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Drug firm Zydus Cadila on Tuesday said it has received final nod from the US health regulator to market generic Clobazam tablets used for treatment of seizures caused by a paediatric 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 paediatric 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.
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