Generic Celecoxib Receives FDA Approval

FDA ApprovedThe U.S. Food and Drug Administration (FDA) approved the first generic versions of celecoxib (Celebrex®, Pfizer, Inc.). Celecoxib may be prescribed in the treatment of rheumatoid arthritis, osteoarthritis, and acute pain.

Two pharmaceutical companies have received approval to market celecoxib.

  • 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 strength products.
  • Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

About Celecoxib
Celecoxib is a non-steroidal anti-inflammatory drug. Prescribing information for celecoxib warns healthcare professionals and patients about the potential risks for heart attack or stroke that may lead to death, and potential life-threatening gastrointestinal bleeding.

In clinical trials, the most commonly reported adverse reactions in patients taking the celecoxib for arthritis were abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, and rash. While taking celecoxib, patients who experience any of these symptoms should contact their prescribing healthcare professional immediately.

Generic Quality Concerns
There are concerns that a generic prescription doesn’t have the same quality as a brand-name drug. However, any generic prescription medication approved by the FDA offers the same quality as their brand-name counterparts. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. The best part about a generic drug is the money saved.

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

Updated on: 08/18/16
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