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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/01/2012
 
Trade Name:  Ultresa
 
Generic or Proper Name (*):  pancrelipase
 
Indications Studied:  Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
 
Therapeutic Category:  Pancreatic enzyme
 
Ages Studied:  1 - < 4 years (weighing 14 kg or more) and patients 4 - 17 years (weighing 28 kg or more)
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Blind/Placebo
 
No Patients:  15
 
No Centers:  8
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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