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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:  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.  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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