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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
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  02/18/2004
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory
 
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