Aurobindo Pharma receives US FDA nod for epilepsy drug levetiracetam

The approved product has an estimated annual market size of $ 32 million in the US

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BS B2B Bureau Hyderabad

Last Updated : Jan 09 2017 | 2:37 PM IST

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

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