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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:  03/26/2008
 
Trade Name:  Ventolin HFA
 
Generic Name or Proper Name (*):  albuterol
 
Indications Studied:  Treatment of symptoms of bronchospasm associated with obstructive airway disease
 
Label Changes Summary:  * Safety and effectiveness of albuterol administered with or without a spacer device in children < 4 years of age has not been demonstrated * 3 randomized, double-blind, placebo-controlled studies in 250 children < 4 years, in which efficacy was not demonstrated, suggest that either the optimal dose has not been defined in this age-group or the drug is not effective in this age-group * Information on clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  08/27/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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