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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:  02/03/2006
Trade Name:  ProAir HFA Inhalation Aerosol
Generic Name or Proper Name (*):  albuterol
Indications Studied:  Prevention of exercise-induced bronchospasm in children 12 years of age and older
Label Changes Summary:  * Expands use from previously approved bronchospasm with reversible obstructive airway disease * Effectiveness based on study in adults and adolescents * Safety and effectiveness in pediatric patients below 12 years of age have not been established * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  IVAX
Therapeutic Category:  Antiasthmatic