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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:  02/01/2008
 
Trade Name:  Asmanex Twisthaler 110mcg inhalation powder
 
Generic Name or Proper Name (*):  mometasone furoate
 
Indications Studied:  Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older
 
Label Changes Summary:  * Not indicated for relief of acute bronchospasm or in children less than 4 years of age * Clinical studies, including 52 week safety trial conducted in children 4  11 years of age * Pediatric dosing information provided * Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering Corporation
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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