Aurobindo Pharma receives US FDA nod for pain killer and epilepsy drug

Aurobindo Pharma has received US Food & Drug Administration (USFDA) approval for a pain killer (celecoxib capsule) and an epilepsy drug (levetiracetam injection).
 
The company received final approval from the US FD to manufacture and market celecoxib capsule (in strengthens 50 mg, 100 mg, 200 mg, and 400 mg). This product is expected to be launched in Q4 FY15-16. Celecoxib capsule, which is generic version of Searle Llc’s Celebrex, has an estimated market size of $ 976 million for the twelve months ending November 2015, according to IMS.
 
Celecoxib capsule is used in the treatment of pain and inflammation of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (2 years and older) ankylosing spondylitis, acute pain in adults, primary dysmenorrhea.
   
US FDA also granted final approval for Aurobindo Pharma’s levetiracetam injection, 500 mg/5 mL (100 mg/mL) single-dose vial, a generic version of UCB’s Keppra injection. Levetiracetam injection is used for the treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures. The approved product has an estimated market size of $ 29 million for the twelve months ending November 2015, according to IMS.