Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Celebrex® Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, of GD Searle, LLC.
Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg is used in the treatment of pain and inflammation of osteo-arthritis, rheumatoid arthritis, Juvenile Rheumatoid Arthritis (2 years and older), ankylosing spondylitis, acute pain in adults, and primary dysmenorrhea.
The product has an estimated market size of $824.9M for the twelve months ending December 2015 according to IMS*.
Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 206 final approvals, including 32 tentative approvals and 10 from Aurolife Pharma LLC. There are 119 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT December 2015