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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  INO Therapeutics
 
Pediatric Exclusivity Granted Date:  11/02/2010
 
NNPS:  FALSE
 
Therapeutic Category:  Pulmonary vasodilator
 
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