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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:  06/22/2010
 
Trade Name:  Dulera Inhalation Aerosol
 
Generic Name or Proper Name (*):  mometasone furoate and formoterol fumarate
 
Indications Studied:  Asthma
 
Label Changes Summary:  * Safety and effectiveness have been established in patients 12 years and older in 3 clinical studies * Safety and efficacy have not been established in children <12 years * Data from clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients * Information on adverse events and clinical studies * New combination
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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