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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
Sponsor:  Merck
Therapeutic Category:  Antiasthmatic; antiallergy