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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:  10/23/2014
 
Trade Name:  Zetonna
 
Generic Name or Proper Name (*):  ciclesonide
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *Efficacy and safety were established in pediatric patients aged 6-11 years with perennial allergic rhinitis in one 12 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial with 846 pediatric patients. *Long-term nasal and ocular safety were evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial in a total of 737 patients 12-74 years of age. Epistaxis was observed in 6% of patients. *Efficacy was not established in pediatric patients aged 6-11 years with seasonal allergic rhinitis in one 2 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial (n= 847) *The effect on the HPA axis was evaluated in one 6 week study in children aged 6-11 years with perennial allergic rhinitis and results were consistent with the fundings observed in the adolescents *The safety in 6 to 11 year old children was similar to patients 12 years and older and no new safety concerns were identified. *Studies in children under 6 years of age have not been conducted
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Takeda
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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