First Generic Version of Celebrex Capsules Approved by FDA

The U.S. health regulators have given a green signal to the first generic version of celebrex used to treat rheumatoid arthritis and other conditions.

In a latest announcement the U.S. Food and Drug Administration reveals that the first common version of Celebrex (celecoxib) capsules was approved to treat patients with rheumatoid arthritis, osteoarthritis, short-term pain and other conditions.

Marketed by Teva Pharmaceutical Industries, the drug will be available in 50 milligrams (mg), 100 mg, 200 mg and 400 mg strengths. It also has a 180 day exclusively on the 100 mg, 200mg and 400 mg strength products. Other than this, Mylan Pharmaceuticals also won the 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. "Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards." 

Being a Non-Steroidal Anti-Inflammatory Drug (NSAID), the newly approved drug contains 'boxed warning' in the prescribing information cautioning health care professionals as well as patients about the risk of heart attack or stroke that can eventually lead to death. This risk increases for those taking the NSAIDs for long periods of time.

During the clinical trials, the most common adverse reaction noticed in patients with arthritis was abdominal pain, diarrhea, indigestion, swollen feet or legs, flatulence, accidental injury, dizziness, inflammation of throat, runny nose, swollen nasal passage, upper respiratory tract infection and rash.

Similar to the other generic drug, this drug has passed the quality standards same as the brand name drugs.