Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-09-06FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approves a supplemental application expanding Prilosec OTC (omeprazole magnesium) to over-the-counter use.
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CLINICAL_TRIALS trial_result · 2013-09-05Clinical Trial Update: GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection
A completed clinical trial from the University of Chicago examined the relationship between gastroesophageal reflux and chronic rejection in…
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FDA approval · 2013-08-27FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Lansoprazole from Mylan Pharmaceuticals Inc., resulting in approval of a generic Lansoprazol…
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FDA approval · 2013-08-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc., resulting in updat…
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FDA approval · 2013-08-16FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy's omeprazole, enabling changes to the previously approved labeling for th…
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CLINICAL_TRIALS trial_result · 2013-08-13Clinical Trial Update: Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease [Phase 3]
A Phase III trial compared Zegerid with Losec for relief of heartburn in gastroesophageal reflux disease, with results posted in 2013.
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FDA approval · 2013-08-07FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc. under ANDA090970, allowing continued marketi…
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FDA approval · 2013-08-06FDA Approved: ESOMEPRAZOLE STRONTIUM — Original Application (R2 Pharma, LLC)
FDA approved esomeprazole strontium via the Original Application (NDA202342) for indications consistent with proton pump inhibitors (GERD-re…
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CLINICAL_TRIALS trial_result · 2013-07-15Clinical Trial Update: Surgery in Chronic Cough GERD Related
A completed clinical trial from the University of Bologna evaluated surgery for gastroesophageal reflux disease–related chronic cough.
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CLINICAL_TRIALS trial_result · 2013-07-08Clinical Trial Update: A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive [Phase 1]
A completed Phase 1 trial evaluating single and multiple doses of rabeprazole in infants aged 1 to 11 months with gastroesophageal reflux di…
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CLINICAL_TRIALS trial_result · 2013-07-03Clinical Trial Update: Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease [Phase 3]
A Phase 3 trial evaluating the efficacy of vonoprazan (TAK-438) versus placebo for non-erosive gastroesophageal reflux disease has completed…
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FDA approval · 2013-06-30FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Omeprazole from Apotex Corp, confirming approval of a supplemental filing for this generic proto…
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FDA approval · 2013-06-13FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for pantoprazole sodium from NorthStar Rx LLC, indicating an approved change to an existing pant…
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CLINICAL_TRIALS trial_result · 2013-06-07Clinical Trial Update: An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients [Phase 2]
Phase 2 exploratory trial evaluating pharmacodynamic effects of SPD557 on reflux parameters in refractory GERD; study terminated with result…
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FDA approval · 2013-05-30FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for pantoprazole sodium submitted by Torrent Pharmaceuticals Limited (generic pantoprazole) under an…
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CLINICAL_TRIALS trial_result · 2013-05-30Clinical Trial Update: Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate [NA]
A prospective, randomized trial evaluates the efficacy of magnesium alginate for treating gastroesophageal reflux in infants; current status…
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CLINICAL_TRIALS trial_result · 2013-05-22Clinical Trial Update: Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD) [Phase 3]
A Phase 3 trial evaluated the safety and efficacy of rabeprazole in infants with gastroesophageal reflux disease. The study is completed and…
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CLINICAL_TRIALS trial_result · 2013-05-22Clinical Trial Update: Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036) [Phase 4]
Phase 4 trial comparing two omeprazole-containing products for relief of frequent heartburn; results have been posted.
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CLINICAL_TRIALS trial_result · 2013-05-21Clinical Trial Update: Confocal Laser Microscopy in Non Erosive Reflux Disease
This completed clinical trial evaluates confocal laser endomicroscopy as a diagnostic approach in non-erosive gastroesophageal reflux diseas…
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FDA approval · 2013-05-17FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Pantoprazole (ANDA077619) filed by NorthStar RxLLC.
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FDA approval · 2013-05-15FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
The FDA approved a supplemental application for Prilosec (omeprazole magnesium) filed by Covis Pharma US, Inc.
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CLINICAL_TRIALS trial_result · 2013-05-06Clinical Trial Update: Epidemiology of Barrett's Esophagus: A Population Based Study
A Mayo Clinic–sponsored population-based study completed to characterize the epidemiology of Barrett's esophagus and its relation to GERD in…
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CLINICAL_TRIALS trial_result · 2013-04-29Clinical Trial Update: A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD) [Phase 1]
Phase 1 pharmacokinetic, pharmacodynamic, and safety study of rabeprazole in newborn infants with gastroesophageal reflux disease has comple…
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FDA approval · 2013-04-19FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC. The action expands or updates…
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FDA approval · 2013-04-19FDA Approved: OMEPRAZOLE/SODIUM BICARBONATE — Original Application (Strides Pharma Science Limited)
FDA approved Strides Pharma Science Limited's generic omeprazole/sodium bicarbonate (original application) for use as a proton pump inhibito…