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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:  10/05/2010
 
Trade Name:  Aridol Powder for Inhalation
 
Generic Name or Proper Name (*):  mannitol
 
Indications Studied:  Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma
 
Label Changes Summary:  * New indication in patients 6 years and older* Efficacy assessed in a total of 246 children and adolescents 6 to 17 years in 2 clinical trials* Bronchial challenge testing should not be performed in children < 6 years due to their inability to provide reliable spirometric measurements * Adverse events similar to adults* Information on adverse events and clinical studies* New indication, dosage form, and route of administration
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pharmaxis
 
NNPS:  FALSE
 
Therapeutic Category:  Diagnostic aid
 
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