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WASHINGTON (AP) - Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.
Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.
However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.
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