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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:
03/11/2005
Trade Name:
Xopenex HFA Inhalation Aerosol
Generic Name or Proper Name (*):
levalbuterol
Indications Studied:
Treatment of bronchospasm in patients with reversible obstructive airway disease in children 4 years of age and older
Label Changes Summary:
Extended indication for use in children down from 6 years of age Pediatric patients have a lower exposure to the drug than adults Population PK model developed from patients down to 4 years of age Effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma. Deferred studies in patients < 4 years of age New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Sepracor
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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