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Pharmacology / Health / Research / Clinical research / Drug discovery / Exocrine pancreatic insufficiency / Pancrelipase / New Drug Application / Orlistat / Pharmaceutical sciences / Food and Drug Administration / Pharmaceutical industry


22222_pancrelipase_Clinical3_PREA
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City

Ultrase / Totowa / Pancrease / /

Company

AEs / Axcan Scandipharm Axcan Scandipharm Digestive Care Eurand SpA / Solvay / Eurand S.p.A. / Axcan Scandipharm Inc. / Organon Inc / Humana Press / /

Country

United States / /

Event

FDA Phase / /

Facility

Laboratory Findings / /

IndustryTerm

physiologic site / enzyme products / drug product / manufacturing / oil / pancreatic enzyme products / energy / /

MedicalCondition

idiopathic pancreatitis-related chronic pancreatitis / abdominal pain / overt diarrhea / disease / exocrine pancreatic insufficiencies / exocrine pancreatic insufficiency / nausea / bloating / chronic loss / pancreatic insufficiency / Pancreatitis / chronic pancreatitis / steatorrhea / cystic fibrosis / pediatric disease / infections / alcoholism / pancreatic cancer / pancreatic enzyme deficiency / /

NaturalFeature

Ultrase® MT / MT. Ultrase / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration / Advisory Committee / Center for Drug Evaluation / FDA NDA / /

Person

Joanna W. Ku / Anne R. Pariser / /

Position

continuous physician / Individual Site Investigator / physician / Clinical Reviewer Clinical Team Leader / /

Product

talc / Cotazym / MT capsules / Oral Capsules / Cotazym® / New Drug / Ultrase® MT / Ultrase / /

ProvinceOrState

New Jersey / Indiana / /

Technology

Pharmacokinetics / Pharmacodynamics / drug development / /

SocialTag