Aurobindo Pharma has received two final approvals from the US Food & Drug Administration (FDA) to manufacture and market levetiracetam injection USP, 500 mg/5 mL (100 mg/mL) single dose vials and for celecoxib capsules, 50mg, 100mg, 200mg and 400mg. The first approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Keppra injection, 500 mg/5 mL (100 mg/mL), of UCB, Inc. and the second ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Celebrex capsules, 50mg, 100mg, 200mg, and 400mg of GD Searle, LLC.
Levetiracetam injection is used for the treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic - clonic seizures. The approved product has an estimated market size of US$ 29 million for the twelve months ending November 2015 according to IMS This is the 23rd ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products.
Celecoxib capsules 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. The approved product has an estimated market size of US $976 million for the twelve months ending November 2015 according to IMS.
Aurobindo now has a total of 236 ANDA approvals (204 Final approvals including 10 from Aurolife Pharma LLC and 32 tentative approvals) from US FDA.