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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:
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
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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