Aurobindo Pharma has received final USFDA approval for generic versions of Levetiracetam injection used for treating epilepsy as well as anti-arthritis drug Celecoxib. The approval for single-dose vials of Levetiracetam injection is for bioequivalent and therapeutically equivalent to the reference listed drug product, Keppra Injection, 500 mg/5 mL (100 mg/mL), of UCB, Inc. Levetiracetam injection is used for treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures.
The product is estimated to have a market size of USD 29 million for the twelve months. This is the 23rd ANDA (abbreviated new drug application), including two tentative approvals, to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products
Company Profile : Aurobindo Pharma Ltd
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