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
 
-
-