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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:  03/31/2004
 
Trade Name:  Zemplar
 
Generic Name or Proper Name (*):  paricalcitol
 
Indications Studied:  Secondary hyperparathyroidism associated with end stage renal disease
 
Label Changes Summary:  * Safety and effectiveness were examined in a 12 week randomized, double-blind, placebo-controlled study of 29 pediatric patients aged 5-19 years old with end stage renal disease on hemodialysis; information * Primary efficacy analysis revealed 9 of 15 patients in Zemplar group had 2 consecutive 30 % decreases from baseline intact PTH compared with 3 of 14 patients in placebo group * No patients in either group developed hypercalcemia (defined as at least one calcium value >11.2 mg/dL) during study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  12/08/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Vitamin D analog
 
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