Generic versions of Celebrex approved

June 2, 2014

FDA approved the first generic versions of Celebrex (celecoxib) last week. The drug is used to treat rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

FDA approved the first generic versions of Celebrex (celecoxib) last week. The drug is used to treat rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

FDA approved Teva Pharmaceutical’s request to market celecoxib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths. Teva also has 180-day exclusivity on the 100-mg, 200-mg, and 400-mg strength products.

Meanwhile, FDA granted Mylan Pharmaceuticals’ request 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.” 

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). As such, it has a boxed warning on its label alerting healthcare professionals and patients about the risk of heart attack or stroke when using NSAIDs.