Generic Versions of Celebrex get Green Signal from FDA for treatment of RA, OA

The first generic versions of Celebrex capsules to target rheumatoid arthritis, osteoarthritis and short-term pain have been approved by the FDA. "It is important for patients to have access to affordable treatment options for chronic conditions. Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards", said Janet Woodcock, MD, Director of the FDA's Center for Drug Evaluation and Research.

The approval for the drug will make generic versions of Celebrex (celecoxib) available in doses of 50-mg, 100-mg, 200-mg and 400-mg. Teva Pharmaceuticals had sought the approval from U. S. FDA to market the drugs for the treatment of patients with rheumatoid arthritis, osteoarthritis and short-term pain. The approval to market 50-mg celecoxib capsules was given to Mylan Pharmaceuticals.

It stated that a warning of heart attack or stroke has been clearly mentioned on the label of the non-steroidal anti-inflammatory drugs so that health care professionals and patients can make informed decisions. Patients taking Celebrex for arthritis during clinical trials often experience abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection and rash.

People who take a Non-Steroidal Anti-Inflammatory Drug (NSAID) for long periods of time have increased chances of suffering heart attack or stroke. The chances are relatively higher for people with heart disease or risk factors like high blood pressure.

The FDA-approved generic prescription drugs have the same high quality and strength as branded drugs. The same quality standards have to be passed by generic drug manufacturing firms and packaging sites as those for branded drugs.

The FDA, an agency within the US Department of Health and Human Services, plays a very important role in protecting public health by assuring the safety, effectiveness and security of humans.


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