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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:  08/30/2012
 
Trade Name:  Revatio
 
Generic Name or Proper Name (*):  sildenafil
 
Indications Studied:  Treatment of pulmonary arterial hypertension
 
Label Changes Summary:  *Use of Revatio, particularly chronic use, is not recommended in children *In a double-blind, placebo-controlled, dose-ranging study, 234 pediatric patients with PAH 1 - 17 years were randomized based on body weight to three dose levels of Revatio, or placebo, for 16 weeks. No patients died during the 16-week study *In a long-term trial, an increase in mortality with increasing dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH * Information on safety, and clinical trials
 
Product Labeling:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  02/09/2012
 
NNPS:  FALSE
 
Therapeutic Category:  Peripheral Vasodilator
 
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