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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/27/2009
 
Trade Name:  Zenpep
 
Generic or Proper Name (*):  pancrelipase
 
Indications Studied:  Exocrine pancreatic insufficiency due to cystic fibrosis
 
Therapeutic Category:  Pancreatic enzyme
 
Ages Studied:  1-17 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Crossover
 
No Patients:  22
 
No Centers:  12
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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