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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:  02/07/2007
Trade Name:  Actiq
Generic Name or Proper Name (*):  fentanyl
Indications Studied:  Treatment of breakthrough pain in opioid tolerant children
Label Changes Summary:  * Safety and efficacy in patients below the age of 16 years was not established in a clinical trial of 15 patients 5 to 15 years * Information on PK parameters and clinical studies
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Cephalon
Therapeutic Category:  Anesthetic agent