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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:
Dymista
Generic Name or Proper Name (*):
azelastine hydrochloride and fluticasone proprionate
Indications Studied:
Treatment of symptoms of seasonal allergic rhinitis
Label Changes Summary:
*Approved for use in pediatric patients 6 to 11 years based on safety and efficacy data from clinical studies of 416 patients and the established efficacy and safety of azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in this age group; previously approved in 12 years and older *Safety findings in children 4-5 years of age were similar to those in children 6-11 years, but efficacy was not established *Safety and effectiveness of have not been studied in pediatric patients below the age of 4 years *Information on clinical trial and adverse reactions *Postmarketing study
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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