The first generic versions of Celebrex (celecoxib) capsules, a treatment for patients with rheumatoid arthritis, osteoarthritis, acute pain, and other conditions, have been approved by the FDA, according to a press release by the agency.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths, and has 180-day exclusivity on the 100-mg, 200-mg, and 400-mg products. Mylan Pharmaceuticals Inc received approval to market 50-mg celecoxib capsules.
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). All NSAIDs have a boxed warning in their prescribing information to alert healthcare professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for heart disease, 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 bleeding that has been associated with the use of NSAIDs.
In the clinical trials for celecoxib, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, swollen nasal passages, sinusitis, upper respiratory tract infection, and rash.
Information about the availability of generic celecoxib can be obtained from the companies.
Last modified: May 21, 2015