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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:  10/22/2009
 
Trade Name:  Atacand
 
Generic Name or Proper Name (*):  candesartan
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * Expanded indication from adults to pediatric patients 1 to < 17 years of age. * Children < 1 year must not receive candesartan. Administering drugs that act directly on the renin-angiotensin system can have effects on the development of immature kidneys * Children with glomerular filtration rate < 30ml/min/1.73m2 should not receive candesartan. * In clinical trials, 4 of 233 children experienced worsening renal disease * Information on preparation of an oral suspension, dosing and administration, adverse events, pharmacokinetics, and clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  07/20/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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