The U.S. Food and Drugs Administration has approved the generic versions of celecoxib to treat rheumatoid arthritis, osteoarthritis and short-term (acute) pain.
Teva Pharmaceutical Industries and Mylan Pharmaceuticals are the two companies that received FDA's approval. The former is now allowed to market the drug 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. The latter 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, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press statement. "Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards."
Celecoxib, marketed as Celebrex, belongs to the category of Non-Steroidal Anti-Inflammatory Drug (NSAID). Such drugs come with a Boxed Warning asking health officials to inform their patients about the risks of taking these drugs, which include heart attack or stroke that can even lead to death. People with high blood pressure are at an increased risk of heart diseases if they take the medication for long duration. The warning also highlights the increased risk of serious, potential life-threatening gastrointestinal (GI) bleeding.
Other side effects of the drug include abdominal pain, diarrhoea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.
The FDA assures that the approved generic versions will have the same high quality and strength as brand-name drugs. According to a Teva press release, the company may launch its generic versions in December, 2014, or earlier under certain circumstances. The company also revealed that sales of Celebrex were $2.2 billion in the U.S. according to IMS data as of December, 2013.
