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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:  01/22/2015
 
Trade Name:  Xopenex Inhalation Solution
 
Generic Name or Proper Name (*):  levalbuterol
 
Indications Studied:  Asthma or reactive airway disease
 
Label Changes Summary:  *Efficacy was not established in one adequate and well controlled trial in 291 pediatric patients from 2 to 5 years, and another adequate and well controlled trial of 88 pediatirc patients from birth to less than 2 years. *Adverse reactions in both studes were consistent with adverse reactions in patients 6 years and older. *Increased number of asthma-related adverse reactions following chronic XOPENEX treatment compared to control. *XOPENEX Inhalation Solution is not indicated for pediatric patients less than 6 years of age
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Oak Pharmaceuticals
 
Therapeutic Category:  Antiasthma
 
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