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Pancrelipase / Exocrine pancreatic insufficiency / Chronic pancreatitis / Cystic fibrosis / Steatorrhea / Adverse event / Fibrosing colonopathy / Malabsorption / Shwachman–Bodian–Diamond syndrome / Pancreas disorders / Health / Medicine


Medical Officer’s Review of Safety Update Report NDA #: 22-222
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Company

McColley SA / Axcan Pharma US Inc. / HP / Axcan Pharma Inc. / /

Country

France / United States / Brazil / Canada / Argentina / Chile / /

Event

FDA Phase / /

IndustryTerm

drug substance manufacturing facility / pancrelipase products / medicinal product / treatment of cystic fibrosis / manufacturing / potential product / /

MedicalCondition

loss of consciousness / abdominal pain / Pseudomonas / acute otitis / moderate abdominal pain / JE / severe diaper dermatitis / young cystic fibrosis / exocrine pancreatic insufficiency / ischemic colitis / vomiting / pancreatic insufficiency / pancreatitis / chronic pancreatitis / developed sinusitis / diarrhea / steatorrhea / cystic fibrosis / MS / constipation / Streptococcal throat infection / /

MedicalTreatment

enzyme replacement therapy / antibiotics / /

NaturalFeature

MT Capsules / /

Organization

Division of Anti-infective and Ophthalmology Products / Cystic Fibrosis Foundation / /

Person

David V / Ali Niak / Benjamin Lorenz / Anil Rajpal / /

Position

reporting physician / author / Acting Team Leader / Medical Officer / /

Product

ULTRASE Capsules / clarithromycin / MT Capsules / ULTRASE® MT Capsules / ULTRASE® MT20 / Creon / ULTRASE® MT12 / ULTRASE / Zenpep / /

Technology

amended protocol / /

SocialTag