Zydus Cadila Gets Final Nod From USFDA To Market Generic Seizures Drug
Drug firm Zydus Cadila on Thursday said it has received final approval from the US health regulator to market generic Lamotrigine extended-release tablets, used to treat certain types of seizures.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Lamotrigine extended-release tablets USP in the strengths of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg, Zydus Cadila said in a statement.
The product will be manufactured at the group's manufacturing facility at special economic zone (SEZ), Ahmedabad, it added.
The group now has 283 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
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