First Generic Version of Celebrax Approved by FDA

First Generic Version of Celebrax Approved by FDA

The U.S. FDA has approved the generic version of painkiller Celebrex (celecoxib) capsules. The cox-2 inhibitor has been a blockbuster drug for treatment of rheumatoid arthritis, osteoarthritis and other painful conditions.

FDA granted approval to Teva Pharmaceuticals for generic version of celecoxib capsules. The capsules will be available in 50mg, 100mg, 200mg and 400mg dosage. The use of non-steroidal anti-inflammatory drugs (NSAID) has increased in the recent years.

The cox-2 inhibitors have been the best selling painkillers under brand name Bextra and Vioxx. The Merck and Co.’s prescription drug Vioxx was pulled out from the market in 2004 after reports of higher risk of heart disease came. Bextra was also withdrawn next year. The pharmaceutical companies faced lawsuit as many patients suffered from heart disease after regular use of Bextra and Vioxx.

The potential side effects of the drug include abdominal pain, indigestion, peripheral edema and sinusitis. FDA official release added, “The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.”

The generic version of celecoxib will also come with a warning label. The drug can lead to higher risk of heart attack or stroke. Medical experts have been advised to carefully analyze the patient’s condition before making prescription for the drug.


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