Marketing for Generic Celebrex Approved by FDA

WASHINGTON – The first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term pain and other conditions, were recently approved by the Food and Drug Administration.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 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.

“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.”

As a nonsteroidal anti-inflammatory drug (NSAID), celecoxib has a Boxed Warning in the prescribing label to alert healthcare professionals and patients about the risk of heart attack or stroke that can lead to death. Risk increases for patients with heart disease or other cardiovascular issues, such as high blood pressure, or those taking NSAIDs for long periods of time. Also highlighted in the Boxed Warning is the risk of serious, potential life-threatening gastrointestinal bleeding, which has been associated with use of NSAIDs.

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