The U.S. Food and Drug Administration (FDA) has approved the first generic versions of pain relieving drug product Celebrex (celecoxib). The medicine is used for treatment of rheumatoid arthritis, osteoarthritis and short-term pain, among other conditions.
The approval issued to Israeli company Teva Pharmaceutical Industries allows the company to manufacture and distribute celecoxib capsules in 50 mg, 100 mg, 200 mg and 400 mg strengths. All types of celecoxib, except for the 50 mg strength, have a 180-day exclusivity period. The regulator also approved marketing of 50 mg celecoxib capsules by Mylan Pharmaceuticals, Inc.
Commenting on the approval, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that it was essential for U.S. consumers to have access to affordable and reliable options for treatment of various chronic conditions. Americans should be aware that approved products have passed rigorous evaluation before receiving approval, she added.
Celecoxib is classed as a non-steroidal anti-inflammatory drug. This means that, like all other products in this group, it will have a boxed warning to alert patients and healthcare professionals that there is a risk of heart attack or death, especially in patients with one or more risk factors present. Other side effects registered in clinical trials include abdominal pain, indigestion and diarrhea, swelling of the feet or legs, dizziness, runny nose and rash, the FDA said.