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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Abbott
Pediatric Exclusivity Granted Date:
12/08/2003
NNPS:
FALSE'
Therapeutic Category:
Vitamin D analog
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