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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Oak Pharmaceuticals
Therapeutic Category:
Antiasthma
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