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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:
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
PREA(P):
P
Sponsor:
Merck
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic; antiallergy
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