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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
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  03/20/2002
Therapeutic Category:  Antihypertensive