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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/15/2006
Trade Name:  Celebrex
Generic Name or Proper Name (*):  celecoxib
Indications Studied:  Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA)
Label Changes Summary:  * New indication in 2 years and older * Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features * Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation * The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults * New 50 mg capsule developed * Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules * Information on dose, clinical studies, PK parameters, AEs
Product Labeling:  Labeling  Opens a new window
Sponsor:  Pfizer
Pediatric Exclusivity Granted Date:  08/23/2006
Therapeutic Category:  Anti-inflammatory