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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:
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Meda
Pediatric Exclusivity Granted Date:
03/23/2015
Therapeutic Category:
Antiallergy
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