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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:  08/19/2004
Trade Name:  Vioxx
Generic Name or Proper Name (*):  rofecoxib
Indications Studied:  Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis
Label Changes Summary:  * Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004.  
Product Labeling:  Labeling  Opens a new window
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  02/18/2004
Therapeutic Category:  Anti-inflammatory