Generic Version of Celebrex Approved by FDA

Celecoxib will be available for the management of pain from rheumatoid arthritis, osteoarthritis and other pain conditions. 

A generic version of the popular anti-inflammatory medication Celebrex (celecoxib) has been approved by the US Food and Drug Administration. The generic celecoxib can be used for the treatment of rheumatoid arthritis, osteoarthritis, and short-term (acute) pain, according to a press release from the FDA.

“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. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a cyclooxygenase (COX)-2 inhibitors (coxibs), a type of  non-steroidal anti-inflammatory drug (NSAID) introduced to the market as safer alternatives to aspirin or ibuprofen (Motrin, Advil). Coxibs are easier on the stomach than traditional    

All NSAIDs have a Boxed Warning in their prescribing information (label) to alert patients about the risk of heart attack or stroke that can lead to death. Celecoxib is the only commercially available coxib—two other coxibs, rofecoxib (Vioxx) and valdecoxib (Bextra), were withdrawn from the market because of increased cardiovascular risks (heart attacks and strokes). 

This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs. Given these risks, the FDA encourages the use of the lowest effective dose of celecoxib for the shortest period of time.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

The capsules will be available in 50 mg, 100 mg, 200 mg, and 400 mg strengths  by Teva Pharmaceutical Industries, which has a 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

Updated on: 07/09/15