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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:  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  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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