Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
PREA(P):  P
 
Sponsor:  IVAX
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
-
-