Aurobindo Pharma receives USFDA Approval for Levetiracetam in Sodium Chloride Injection

Hyderabad : Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) 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) (Single-use bags). Aurobindo’s Levetiracetam in Sodium Chloride Injection is a generic equivalent of HQ Specialty Pharma Corp’s Levetiracetam in Sodium Chloride Injection. The product will be launched in Jan 2017.

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 generalized epilepsy. The approved product has an estimated market size of US$ 32 million for the twelve months ending November 2016 according to IMS.

This is the 41st ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 304 ANDA approvals (263 Final approvals including 16 from Aurolife Pharma LLC and 41 tentative approvals) from USFDA.