Zenpep Clinical Studies

TMA DoD Pharmacoeconomic Center Fort Sam Houston, TX
(PORT) Cost effectiveness reviews for P&T Formulary changes (“closing the loop”) Effects of Tier 3 status (2 studies) Effects of step therapy, clinical impact (PPI study) Past and potential policy changes Fentanyl patch safety and Zenpep With regards to other factors such as ... Fetch Full Source

DEPARTMENT OF DEFENSE PHARMACY AND THERAPEUTICS COMMITTEE ...
Relative Clinical Effectiveness-Tekamlo is a fixed-dose combination product studies have shown an increase in persistence with fixed-dose antihypertensive Zenpep were approved for marketing in 2009 and Pancreaze was approved in April ... Retrieve Full Source

Cystic Fibrosis Foundation Therapeutics Pipeline
PRE-CLINICAL Initial Testing in Laboratory PHASE 1 Human Safety Trial PHASE 2 Follow-on studies are determining if younger patients would benefit from this inhaled therapy. Eurand Pharmaceuticals (Zenpep®), Abbott (Creon®) ... Visit Document

Pancreatic Exocrine Insufficiency
Zenpep 3,000 3,000 16,000 10,000 Zenpep 5,000 5,000 27,000 17,000 and reported studies have not demonstrated a clear benefit associated with this strategy.29,34-36 Third, clinical response is to distribute nutrient intake across 5 ... Access Doc

Check Out The Allscripts’ Advantage
Looked at medication-error reports from two studies that examined mistakes from recommended for approval 11/08; CR 12/08; FDA wants additional non-clinical studies performed; FDA wants proof paliperidone palmitate (Invega Sustenna), pancrelipase (Zenpep), pazopanib (Votrient ... Doc Viewer

Testimony To The FDA Gastrointestinal Drug Advisory Committee ...
Ethics of Further Clinical Trials January 12, 2011 Michael Carome, M.D. Creon Zenpep Pancreaze Baseline CFA Category Study 726 Liprotam. studies that should be obtained prior to approving liprotamase for EPI? Response: ... Access This Document

Pancreatic Exocrine Insufficiency
Creatic enzyme replacements.12 Clinical therapeutic Zenpep 3,000 3,000 16,000 10,000 Zenpep 5,000 5,000 27,000 17,000 studies have suggested that methacrylic acid copoly-mer, which is used as the acid-resistant coating on cer- ... Access This Document

SOCIETY OF CLINICAL ONCOLOGY SAN FRANCISCO – A small eral studies have shown that IPMN represents a field defect of ductal instability, and although many have focused on the risk of quality” are Creon and Zenpep ... Read Full Source

Cystic Fibrosis Foundation- Carolinas Chapter Newsletter
“Phase 2 studies of ataluren showed encouraging results, and we are pleased to be supporting this study.” In July 2008, The FDA is requiring all pancreatic enzyme replacement products on the market to be reformulated and undergo clinical testing. ZENPEP, ... Fetch This Document

July 2011 Erythropoiesis Stimulating Agents ( ESA) Dosing In ...
In studies, lowering LDL-C has been shown to reduce risk of CV events. However, increasing high-density lipoprotein pancrelipase Zenpep® Zenpep® has a new strength of capsule of 3,000 USP units of Clinical benefit such as improvement in overall survival has not been ... Access Full Source

PrIVyeT! RuSSIa
Tribute Zenpep, subject to regulatory review and approval, in Russia and the Common-wealth of Independent States (CIS). clinical research and initiation of clinical studies. Johnson & Johnson entered a partner-ship with Russia’s largest drug-maker Pharm- ... Fetch Document

Drug Use Research & Management Program Phone 503-947-5220 | Fax
Agents: CREON®, ZENPEP®, LIPASE clinical trials, patient diets were developed by nutritionists and tightly controlled days to 2 to 3 weeks. The primary efficacy endpoint used in most studies included the ... Fetch Content

Hospital Pharmacy Current FDA-Related Drug Information
Zenpep enzymes exocrine pan- and amylase pain, flatulence, capsule com/pdfs/zenpep_ (Eurand) creatic insuffi- replacement headache, relapsed ovarian cancer and additional clinical pharmacology studies Recommended for Approval by an FDA Advisory Panel ... Read Document

State Medicaid Pharmacy And Therapeutics Committee Meeting ...
Pancrelipase (amylase/lipase/protease), Zenpep (amylase/lipase/protease) 8. Glucagon-like-Peptide-1 New clinical information may include a new drug or drug product information, new Any studies cited should be referenced, ... View Document

Alaska Medicaid Pharmacy And Therpeutics Committee
Zenpep is the only drug used for tube clinical and safety information from a naturalistic or observational perspective. Care in the open label extension portion of several pivotal studies, which were reviewed. Treatment with ... Doc Viewer

Drug Information Update Dec 09
PANCREATIC ENZYME ZENPEP CAPSULE DR AMYLASE/ LIPASE/ PROTEASE 27K-5K-17K, 55-10- 34K, 82-15- 51K, The approval is based on clinical data based on studies in that disease begun in 2007, said Wolfgang Wein, ... Retrieve Full Source

CliniCal Update
CliniCal update Pancreatic Insufficiency Advances in the Treatment of Pancreatic Insufficiency , and Zenpep (Eurand) For Creon, 2 major studies were conducted: a ... Doc Viewer

Side Effect Management Through Diet & Nutrition
– Zenpep ® – Ultresa ® Prevalence and clinical profile of pancreatic cancer-associated diabetes mellitus. Gastroenterology 134: 981-987 three large-case control studies. Cancer Causes Cntrol.Published on-line: 21 November 2010. Fearon, C. et al ... Retrieve Content