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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:  02/04/2010
 
Trade Name:  Benicar
 
Generic Name or Proper Name (*):  olmesartan
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * Expanded indication from adults to pediatric patients 6 years and older * Information on preparation of an oral suspension * Adverse events similar to adult patients * Information on dosing, adverse reactions, pharmacokinetics, and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Daiichi Sankyo
 
Pediatric Exclusivity Granted Date:  10/07/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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