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FDA Approves Generic Version of Celebrex

Rx will carry warning alerting users of potential heart risks

MONDAY, June 2, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Friday gave its approval to the first generic version of the pain reliever Celebrex (celecoxib).

On Friday, Teva Pharmaceutical Industries got the nod from the FDA to market generic versions of celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. Mylan Pharmaceuticals Inc. received permission to market 50 mg celecoxib capsules, the agency said.

According to the FDA, like all nonsteroidal anti-inflammatory drug (NSAID) medications, generic celecoxib will "have a Boxed Warning in their prescribing information (label) to alert health care 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 it, such as high blood pressure, or taking NSAIDs for long periods of time."

"It is important for patients to have access to affordable treatment options for chronic conditions," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in an agency statement. "Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards."

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