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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:  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 study* During 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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  02/09/2012
 
NNPS:  FALSE
 
Therapeutic Category:  Peripheral vasodilator
 
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