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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:
11/21/2007
Trade Name:
Omnaris Nasal Spray
Generic Name or Proper Name (*):
ciclesonide
Indications Studied:
Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age
Label Changes Summary:
Indication extended down to 6 years of age Pediatric dosing information provided Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Nycomed US Inc.
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic; antiallergy
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