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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:  07/27/2005
 
Trade Name:  Singulair Oral Granules, Tablets, and Chewable Tablets
 
Generic Name or Proper Name (*):  montelukast
 
Indications Studied:  Relief of symptoms of perennial allergic rhinitis in children 6 months of age and older
 
Label Changes Summary:  *Effectiveness was extrapolated from a allergic rhinitis study in patients 15 years of age and older * Safety in patients 6 to 23 months is supported by data from PK and safety and efficacy studies in asthma in this pediatric population and from adult PK studies * Studies waived in children < 6 months of age * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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