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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:
12/21/2010
Trade Name:
INOmax
Generic Name or Proper Name (*):
nitric oxide
Indications Studied:
Prevention of bronchopulmonary dysplasia
Label Changes Summary:
INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants Information on clinical trials, adverse reaction
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
INO Therapeutics
Pediatric Exclusivity Granted Date:
11/02/2010
NNPS:
FALSE'
Therapeutic Category:
Pulmonary vasodilator
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