FDA Approves Generic Form of Celecoxib

May 30, 2014

The US Food and Drug Administration has approved generic forms of the nonsteroidal anti-inflammatory drug celecoxib, used for rheumatoid arthritis and osteoarthritis as well as acute pain.

The US Food and Drug Administration announced today that it has approved a generic version of the COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) celecoxib, which is used for rheumatoid arthritis and osteoarthritis as well as for acute pain.

Two manufacturers are licensed to market the drug: Mylan Pharmaceuticals in a 50-mg formulation and Teva Pharmaceuticals in 50-mg, 100-mg, 200-mg, and 400-mg formulations with 180-day exclusivity on the latter three dosages.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock MD, director of the FDA’s Center for Drug Evaluation and Research.

Although the drug label carries warnings about cardiovascular as well as gastrointestinal risks, a recent prospective 3-year nationwide observational study from Japan involving more than 11,000 patients with osteoarthritis and rheumatoid arthritis found no significant difference between celecoxib and other NSAIDs for any of a number of cardiovascular outcomes including myocardial infarction, stroke, and cardiovascular death.