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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
Sponsor:  Wyeth
Therapeutic Category:  Antidepressant