• 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:  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
Sponsor:  GlaxoSmithKline
Pediatric Exclusivity Granted Date:  08/27/2008
Therapeutic Category:  Antiasthmatic