Exocrine Pancreatic Insufficiency
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-04-10FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc.
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CLINICAL_TRIALS trial_result · 2015-03-11Clinical Trial Update: Enzyme Suppletion in Exocrine Pancreatic Dysfunction [Phase 4]
Phase 4 trial update reporting completion of a study on enzyme supplementation for exocrine pancreatic dysfunction, including chronic pancre…
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FDA approval · 2015-03-03FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
The FDA approved a supplemental application for PANCREAZE (pancrelipase) from VIVUS LLC.
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FDA approval · 2015-01-05FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating its labeling to support its use for exocrine panc…
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FDA label_change · 2014-11-21FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating the labeling to reflect approved uses for exocrine pa…
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FDA approval · 2014-11-19FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc.
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CLINICAL_TRIALS trial_result · 2014-11-18Clinical Trial Update: Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency [Phase 2]
Phase 2 trial results evaluating Bucelipase alfa (BSSL) in cystic fibrosis patients with exocrine pancreatic insufficiency. Results were pos…
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CLINICAL_TRIALS trial_result · 2014-10-24Clinical Trial Update: Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency [Phase 3]
A Phase 3 trial of Liprotamase in cystic fibrosis-related exocrine pancreatic insufficiency has completed.
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CLINICAL_TRIALS trial_result · 2014-10-24Clinical Trial Update: Phase III ALTU-135 CP Safety Trial [Phase 3]
Phase III safety trial ALTU-135 CP for exocrine pancreatic insufficiency was terminated.
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CLINICAL_TRIALS trial_result · 2014-10-24Clinical Trial Update: Open-Label Phase III Long-Term Safety Trial of Liprotamase [Phase 3]
The open-label Phase III long-term safety trial of Liprotamase has completed.
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FDA approval · 2014-09-26FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for Zenpep (pancrelipase) submitted by Aimmune Therapeutics, expanding or updating its labeling/…
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FDA approval · 2014-07-29FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for VIOKACE (pancrelipase) from Aimmune Therapeutics, Inc.
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FDA label_change · 2014-06-23FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for PANCREAZE (pancrelipase) from VIVUS LLC.
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CLINICAL_TRIALS withdrawal · 2014-06-20Clinical Trial Update: A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2 [Phase 4]
A Phase 4 clinical trial evaluating Creon (pancrelipase) for pancreatic exocrine insufficiency in subjects with type 2 diabetes mellitus has…
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CLINICAL_TRIALS trial_result · 2014-04-10Clinical Trial Update: Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency [Phase 4]
Phase 4 clinical trial update on controlling steatorrhea in participants with cystic fibrosis and exocrine pancreatic insufficiency; results…
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CLINICAL_TRIALS trial_result · 2014-04-10Clinical Trial Update: A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age [Phase 4]
This Phase 4 trial evaluated the mode of administration and safety of EUR-1008 (APT-1008) in infants aged 1 to 12 months with cystic fibrosi…
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CLINICAL_TRIALS trial_result · 2014-04-04Clinical Trial Update: Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency [Phase 3]
Phase 3 study evaluating the safety and efficacy of EUR-1008 (APT-1008) pancreatic enzyme product in cystic fibrosis patients with exocrine …
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CLINICAL_TRIALS trial_result · 2014-04-04Clinical Trial Update: Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency [Phase 3]
A Phase 3 trial evaluating a pancreatic enzyme product in pediatric participants with cystic fibrosis and exocrine pancreatic insufficiency …
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CLINICAL_TRIALS trial_result · 2014-03-14Clinical Trial Update: Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. [Phase 3]
A Phase 3 safety and efficacy trial evaluating two pancreatic enzyme formulations for exocrine pancreatic insufficiency in cystic fibrosis h…
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CLINICAL_TRIALS trial_result · 2014-03-12Clinical Trial Update: Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI) [Phase 3]
Phase 3 safety and efficacy results for ULTRASE MT20 in people with cystic fibrosis and exocrine pancreatic insufficiency, with the study co…
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CLINICAL_TRIALS trial_result · 2014-03-12Clinical Trial Update: Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea [Phase 3]
Phase 3 safety and efficacy study of Viokase 16 for correcting steatorrhea in exocrine pancreatic insufficiency and chronic pancreatitis; th…
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CLINICAL_TRIALS trial_result · 2014-03-12Clinical Trial Update: A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) [Phase 3]
Phase 3 randomized, double-blind, dose-response crossover trial evaluating two doses of EUR-1008 (APT-1008) in chronic pancreatitis with exo…
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FDA approval · 2014-03-07FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for PANCREAZE (pancrelipase) submitted by VIVUS LLC.
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CLINICAL_TRIALS trial_result · 2014-03-07Clinical Trial Update: PR-018: An Open-Label, Safety Extension of Study PR-011 [Phase 4]
Open-label safety extension of study PR-011 (PR-018) in Cystic Fibrosis with Exocrine Pancreatic Insufficiency; Phase 4 completed with resul…
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FDA approval · 2014-01-23FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA approves a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., expanding its labeling/indication.