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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:
03/06/2014
Trade Name:
Revatio
Generic Name or Proper Name (*):
sildenafil
Indications Studied:
Treatment of pulmonary arterial hypertension (PAH)
Label Changes Summary:
Labeling updated to include information on results of an open-label pediatric safety extension studyDuring the study, there were 42 deaths with 37 of these deaths reported prior to a decision to titrate patients to a lower dosage because of a finding of increased mortality. An increase in mortality was observed with increasing doses Causes of death in the extension study were typical of patients with PAH
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
02/09/2012
NNPS:
FALSE'
Therapeutic Category:
Peripheral vasodilator
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