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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:  01/27/2017
 
Trade Name:  Symbicort Inhalation Aerosol
 
Generic Name or Proper Name (*):  budesonide/formoterol fumarate dihydrate
 
Indications Studied:  Asthma in pediatric patients 6 to less than 12 years
 
Label Changes Summary:  *Expanded indication down to 6 to less than12 years; previously approved down to pediatric patients 12 years and older. * Safety and effectiveness in asthma patients less than 6 years have not been established. *Safety profile in pediatric patients 6 to less than 12 years was similar to that observed in patients 12 years of age and older.*Information on dosing, adverse reactions, and clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  01/25/2017
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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