Aurobindo Pharma receives USFDA Approval for Celecoxib Capsules

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg. This product is expected to be launched in Q4 FY15-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Celebrex Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, of GD Searle, LLC.

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.

This is the 61st ANDA (including 11 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. the company now has a total of 235 ANDA approvals (203 Final approvals including 10 from Aurolife Pharma LLC and 32 Tentative approvals) from USFDA.