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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:  10/13/2017
 
Trade Name:  Butrans transdermal system
 
Generic Name or Proper Name (*):  buprenorphine
 
Indications Studied:  Treatment of moderate-to severe chronic pain requiring continuous, around-the clock opioid treatment for an extended period of time
 
Label Changes Summary:  *Safety and efficacy in patients under 18 years of age have not been established. *Butrans has been evaluated in an open-label clinical trial in pediatric patients. However, definitive conclusions are not possible because of the small sample size. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Purdue
 
NNPS:  FALSE
 
Therapeutic Category:  Analgesic
 
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