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New Pediatric Labeling Information Database - Detail
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Pediatrics
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:
Labeling
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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