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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:  02/20/2015
 
Trade Name:  Astepro Nasal Spray
 
Generic Name or Proper Name (*):  azelastine
 
Indications Studied:  Seasonal allergic rhinitis; Perennial allergic rhinitis
 
Label Changes Summary:  *One 4-week open-label study of 191 pediatric patients from 6 months to 5 years established safety and reduced allergic rhinitis sympsoms. These data supported treatment of: * Seasonal allergic rhinitis in patients aged 2 though 6 years, including dosing information *Perennial allergich rhinitis in pediatric patients aged 6 months through 6 years, including dosing information. *The safety and effectiveness of ASTEPRO in patients below 6 months of age have not been established
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Meda
 
Pediatric Exclusivity Granted Date:  03/23/2015
 
Therapeutic Category:  Antiallergy
 
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