FDA Approves First Generic Versions of Celebrex (Celecoxib)
Teva and Mylan crash the party
The FDA has OK’d the first generic versions of Celebrex (celecoxib, Pfizer) capsules, a treatment for rheumatoid arthritis (RA), osteoarthritis (OA), acute pain, and other conditions.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50-, 100-, 200-, and 400-mg strengths, and has 180-day exclusivity on the 100-, 200-, and 400-mg products. Mylan Pharmaceuticals, Inc. received approval to market 50-mg celecoxib capsules.
“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 nonsteroidal anti-inflammatory drug (NSAID). All NSAIDs have a boxed warning in their prescribing information to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This risk is increased in people with heart disease or risk factors for it, such as hypertension, or in people who have been taking NSAIDs for long periods. The boxed warning also highlights the risk of serious, potentially life-threatening gastrointestinal bleeding, which has been associated with the use of NSAIDs.
As an NSAID, celecoxib exhibited anti-inflammatory, analgesic, and antipyretic activities in animal models. The drug’s mechanism of action is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). At therapeutic concentrations in humans, celebrex does not inhibit the COX-1 isoenzyme.
Celebrex (celecoxib) is indicated for RA, OA, juvenile RA (in patients 2 years of age and older), ankylosing spondylitis, acute pain, and primary dysmenorrhea.
In clinical trials of celecoxib, the most commonly reported adverse events in patients with arthritis included abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, and rash.
According to the FDA, generic prescription drugs approved by the agency have the same quality and strength as brand-name drugs. In addition, generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name treatments.