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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:
03/23/2016
Trade Name:
Cinqair
Generic Name or Proper Name (*):
reslizumab
Indications Studied:
Asthma in patients 12 to 17 years
Label Changes Summary:
* The safety and effectiveness in pediatric patients have not been established. * CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with CINQAIR than placebo. * Information on clinical trials. * New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Teva Respiratory, LLC
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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