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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Meda
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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