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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:  11/16/2001
 
Trade Name:  Calcijex
 
Generic Name or Proper Name (*):  calcitriol
 
Indications Studied:  Management of hypocalcemia in patients undergoing chronic renal dialysis
 
Label Changes Summary:  * The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. * The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients * Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  02/16/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Vitamin
 
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