Aurobindo Pharma 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). This product is a generic equivalent of HQ Specialty Pharma Corp’s Levetiracetam in Sodium Chloride Injection. The product will be launched in Jan 2017. This product 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 $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.
Aurobindo Pharma is one of the leading Indian pharmaceutical research companies that manufactures and export drugs and formulations worldwide. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.
