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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:  03/12/2015
 
Trade Name:  Xopenex HFA Inhalation
 
Generic Name or Proper Name (*):  levalbuterol
 
Indications Studied:  Asthma or reactive airway disease
 
Label Changes Summary:  *Not indicated for pediatric patients less than 4 years of age. A 4 week randomized, placebo-controlled clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint *There was an increased incidence of asthma-related adverse reactions reported in Xopenex HFA-treated pediatric patients compared to placebo in this age group *Information on clinical trial *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sunovion Pharmaceuticals
 
Therapeutic Category:  Antiasthmatic
 
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