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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:
05/30/2007
Trade Name:
Zyflo CR Extended Release Tablets
Generic Name or Proper Name (*):
zileuton
Indications Studied:
Prevention and chronic treatment of asthma in children 12 years of age and older
Label Changes Summary:
Should not be used in children under 12 years of age Effectiveness was established in clinical studies that included pediatric patients 12 years of age and older Short-term and long-term safety were established in clinical studies that included pediatric patients 12 years of age and older Studies waived in children 0-4 years of age and deferred in children 5-11 years of age New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Critical Therapeutics
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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