 "Aurobindo Pharma receives US FDA nod for epilepsy drug levetiracetam")
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture and market levetiracetam in sodium chloride injection, 500 mg/100 mL (5 mg/mL), 1000 mg/100 mL (10 mg/mL), and 1500 mg/100 mL (15 mg/mL). The approved product is a generic equivalent of HQ Specialty Pharma Corp’s levetiracetam in sodium chloride injection. The product is expected to be launched this month.
Levetiracetam in sodium chloride injection is a CNS drug and indicated for partial onset seizures in adults (16 years and older) with epilepsy; myoclonic seizures in adults with juvenile myoclonic epilepsy; primary generalised tonic-clonic seizures in adults with idiopathic generalised epilepsy.
The approved product has an estimated market size of $ 32 million for the twelve months ending November 2016, according to IMS.
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