Exocrine Pancreatic Insufficiency
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-12-09FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics.
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FDA approval · 2013-04-11FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics.
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FDA approval · 2013-03-14FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for CREON (pancrelipase) by AbbVie.
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CLINICAL_TRIALS trial_result · 2013-02-22Clinical Trial Update: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) [NA]
A clinical trial evaluating the bioavailability of pancreatic enzyme products in the human upper small intestine (duodenum and jejunum) spon…
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CLINICAL_TRIALS trial_result · 2013-02-22Clinical Trial Update: Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control [Phase 4]
Phase 4 intraduodenal aspiration study evaluating the bioavailability of the oral pancrecarb versus placebo in exocrine pancreatic insuffici…
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FDA approval · 2012-12-07FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
The FDA granted a supplemental approval for PANCREAZE (pancrelipase) to VIVUS LLC.
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FDA approval · 2012-11-20FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) submitted by AbbVie Inc. The action involves modifications to the produ…
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FDA approval · 2012-05-17FDA Approved: PERTZYE — Original Application (Digestive Care, Inc.)
PERTZYE (pancrelipase) was approved on an original application for the treatment of exocrine pancreatic insufficiency.
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FDA approval · 2012-03-01FDA Approved: VIOKACE — Original Application (Aimmune Therapeutics, Inc.)
FDA approved Viokace (pancrelipase) via an original application from Aimmune Therapeutics, establishing a pancrelipase therapy for exocrine …
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CLINICAL_TRIALS trial_result · 2011-07-28Clinical Trial Update: A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency [Phase 3]
This clinical trial update reports the completion of a Phase 3 study evaluating SA-001 for exocrine pancreatic insufficiency associated with…
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FDA approval · 2011-07-13FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for Zenpep (pancrelipase) submitted by Aimmune Therapeutics, authorizing changes to labeling rel…
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FDA approval · 2011-07-12FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc., updating its labeling to reflect indications for exoc…
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FDA approval · 2011-06-20FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for PANCREAZE filed by VIVUS LLC.
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FDA label_change · 2011-06-15FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, resulting in changes to the product lab…
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FDA approval · 2011-06-10FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie.
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CLINICAL_TRIALS trial_result · 2011-05-19Clinical Trial Update: A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI) [Phase 1]
Phase 1 trial evaluating the enzyme Pancrelipase for safety and enzyme activity in patients with exocrine pancreatic insufficiency; the stud…
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CLINICAL_TRIALS trial_result · 2010-10-28Clinical Trial Update: Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency [Phase 2, Phase 3]
A Phase 2/3 clinical trial reports non-inferiority of Norzyme pancreatic enzyme replacement therapy compared with Creon in patients with Exo…
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FDA approval · 2010-08-12FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating its labeling/indication as part of a supplemental…
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FDA approval · 2010-04-30FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
FDA approves a supplemental application for CREON (pancrelipase) submitted by AbbVie.
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CLINICAL_TRIALS trial_result · 2010-03-17Clinical Trial Update: A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency [Phase 3]
Phase 3 trial evaluating the efficacy and tolerability of Pancrelipase Microtablet Capsules for exocrine pancreatic insufficiency in cystic …
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CLINICAL_TRIALS trial_result · 2010-02-11Clinical Trial Update: An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI) [Phase 2]
An open-label Phase 2 trial evaluated intraduodenal delivery of enzymes from VIOKASE16 in exocrine pancreatic insufficiency and has complete…
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FDA approval · 2009-08-27FDA Approved: ZENPEP — Original Application (Aimmune Therapeutics, Inc.)
FDA approves Zenpep (pancrelipase) in an Original Application for the treatment of exocrine pancreatic insufficiency due to conditions such …
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FDA approval · 2009-04-30FDA Approved: CREON — Original Application (AbbVie Inc.)
FDA approved CREON (pancrelipase) under AbbVie’s original Biologics License Application, authorizing its marketing for exocrine pancreatic i…