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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:  03/11/2004
 
Trade Name:  Cozaar
 
Generic Name or Proper Name (*):  losartan
 
Indications Studied:  Hypertension
 
Label Changes Summary:  Antihypertensive effects established in hypertensive patients 6-16 years of age Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/ min/1.73 m2 due to no data Information on PK and dose in pediatric patients 6-16 years of age. No relevant differences between the AE profile for pediatric patients compared to reported AEs for adults Information on preparation of a suspension
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  03/20/2002
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihypertensive
 
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