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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:  06/06/2002
 
Trade Name:  Pepcid
 
Generic Name or Proper Name (*):  famotidine
 
Indications Studied:  Gastroesophageal reflux
 
Label Changes Summary:  * Labeling for patients less than 1 year of age including information on dose, PK/PD parameters and AE profile * Lower dose recommended in patients <3 months of age * Pediatric patients 0-3 months of age had clearance values 2 to 4-fold less than those in older patients and adults * In a clinical study of 35 pediatric patients <1 year of age, agitation was observed in 5 patients on famotidine and resolved upon discontinuation of the drug
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  11/21/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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