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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:
03/26/2012
Trade Name:
Singulair Oral Granules, Tablets, and Chewable Tablets
Generic Name or Proper Name (*):
montelukast
Indications Studied:
Prevention of exercise-induced bronchoconstriction
Label Changes Summary:
Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older Efficacy for prevention of EIB in patients < 6 years of age has not been established Information on clinical trial, and dosing Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Merck
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic; antiallergy
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