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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:
08/30/2013
Trade Name:
Astepro Nasal Spray
Generic Name or Proper Name (*):
azelastine
Indications Studied:
Treatment of perennial and seasonal allergic rhinitis
Label Changes Summary:
Expanded the indication to pediatric patients down to 6 years; previously approved in pediatric patients 12 years and older Safety and effectiveness in pediatric patients < 6 years have not been established Information on dosing, clinical trial, and adverse reactions Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Meda
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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