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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:  02/26/2003
 
Trade Name:  Pulmicort
 
Generic Name or Proper Name (*):  budesonide
 
Indications Studied:  Maintenance and Prophylaxis of Asthma
 
Label Changes Summary:  Safety information in pediatric patients 6 to 12 months of age A dose dependent effect on growth was observed in the 12-week trial which supports the finding that the use of Pulmicort Respules in infants 6 to 12 months of age may result in systemic effects and is consistent with the findings of growth suppression in other studies with inhaled corticosteroids Pneumonia was observed more frequently in patients treated with Pulmicort Respules than in patients treated with placebo
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  11/12/2002
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
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