First Generic Versions of Celebrex (celecoxib) Approved by FDA

On May 30, the FDA announced the approval of the first generic versions of Celebrex (celecoxib) capsules for the treatment of rheumatoid arthritis, osteoarthritis, acute pain, and other conditions.1 Both Teva Pharmaceutical Industries and Mylan Pharmaceuticals Inc have received approval to market 50 mg celecoxib capsules. (Teva has a 180-day exclusivity on the 100 mg, 200 mg, and 400 mg doses.)

Earlier this year, Pfizer (the manufacturer of Celebrex) and Teva reached a settlement after a federal court invalidated a patent that would have given Pfizer 18 more months of U.S. exclusivity to sell Celebrex.2 Pfizer was granted a “reissue patent” covering methods of treating osteoarthritis and other approved conditions with the celecoxib that was later invalidatd by the federal appeals court. Pfizer had intended for the reissued patent to extend patent protection for until Dec. 2, 2015. Last year, Celebrex generated approximately $2.2 billion in sales in the U.S.3

The availability of generic celecoxib provides people with access to more affordable treatment options that are as safe and effective as their brand-name counterpart.1 Generic prescription drugs that are approved by the FDA are of the same quality and strength as the brand-name drugs. Additionally, sites that manufacture and package these generic drugs are required to pass the same quality standards as those of the brand-name products.

Celecoxib, as with all other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), has a Boxed Warning in the prescribing information regarding an increase in cardiovascular and gastrointestinal risks.4 Celecoxib, and other NSAIDs, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Additionally, NSAIDs are associated with an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. In clinical trials of celexocib (for the treatment of arthritis), the most commonly reported adverse events included abdominal pain, diarrhea, indigestion, flatulence, peripheral edema, and upper respiratory tract infection. Of course, it is important to discuss the benefits and risks of any drug with your doctor before starting a new treatment regimen.

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