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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
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  11/12/2002
Therapeutic Category:  Antiasthmatic