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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:
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
PREA(P):
P
Sponsor:
Sunovion Pharmaceuticals
Therapeutic Category:
Antiasthmatic
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