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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
Therapeutic Category:  Antihypertensive