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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:  12/01/2005
 
Trade Name:  Effexor XR Extended-Release Capsules
 
Generic Name or Proper Name (*):  venlafaxine
 
Indications Studied:  Social anxiety disorder
 
Label Changes Summary:  Provided additional safety data for changes in weight, height, and appetite occurring in pediatric patient Information based on a clinical study of patients with SAD New indication (not approved in pediatric patients)
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Wyeth
 
NNPS:  FALSE'
 
Therapeutic Category:  Antidepressant
 
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