New Delhi: Drug firm Aurobindo Pharma has received final approval from the US health regulator for its Levetiracetam in Sodium Chloride injection used for treatment of seizures with epilepsy.
The company “has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Levetiracetam in Sodium Chloride injection, 500 mg/100 mL (5 mg/mL), 1,000 mg/100 mL (10 mg/mL), and 1,500 mg/100 mL (15 mg/mL) (single-use bags),” Aurobindo Pharma said in a filing to BSE.
The product is a generic version of HQ Specialty Pharma Corp’s Levetiracetam in Sodium Chloride injection, it added.
“The product will be launched in Jan 2017,” Aurobindo Pharma said.
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 generalized tonic-clonic seizures in adults with idiopathic generalised epilepsy, it added.
“The approved product has an estimated market size of USD 32 million for the twelve months ending November 2016 according to IMS,” Aurobindo Pharma said.
Aurobindo Pharna currently has a total of 304 Abbreviated New Drug Application (ANDA) approvals (263 final approvals including 16 from Aurolife Pharma LLC and 41 tentative approvals) from US FDA, it added.