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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Critical Therapeutics
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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