The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.
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 received approval to market 50 mg celecoxib capsules.
Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.
Information about the availability of generic celecoxib is available from the companies.
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