Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-07-07FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)
FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole). This approval supports updates to labeling and expan…
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CLINICAL_TRIALS trial_result · 2021-06-21Clinical Trial Update: Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing [NA]
Completed clinical trial comparing genotype-guided dosing to conventional dosing of proton pump inhibitors for gastroesophageal reflux disea…
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CLINICAL_TRIALS trial_result · 2021-06-08Clinical Trial Update: Observational Study of Anti-Reflux Surgery
Observational study on anti-reflux surgery for GERD has completed; results posted in 2021.
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FDA approval · 2021-06-04FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Pantoprazole Sodium (Sun Pharmaceutical Industries, Inc.), resulting in updated labeling for…
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FDA approval · 2021-04-20FDA Approved: FAMOTIDINE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' Original Application for famotidine, a generic H2 blocker, enabling marketing for ulcers and gastroeso…
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FDA approval · 2021-03-19FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Biocon Pharma Inc.,)
FDA approved Biocon Pharma's Original Application for esomeprazole magnesium, a generic proton pump inhibitor, enabling marketing of a lower…
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CLINICAL_TRIALS trial_result · 2021-02-21Clinical Trial Update: An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD [Phase 2]
Phase 2 trial updating the efficacy and safety of XP19986 in symptomatic gastroesophageal reflux disease.
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CLINICAL_TRIALS trial_result · 2021-02-21Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) [Phase 2]
Phase 2 trial update evaluating arbaclofen placarbil as adjunctive therapy for gastroesophageal reflux disease completed.
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FDA approval · 2021-02-19FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for famotidine submitted by Chartwell RX, LLC (ANDA 075786). It authorizes changes to the approved g…
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CLINICAL_TRIALS trial_result · 2021-02-17Clinical Trial Update: Fexofenadine Use in Gastroesophageal Reflux Symptoms [Phase 2]
Phase 2 trial evaluating fexofenadine for gastroesophageal reflux symptoms was terminated with results posted.
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FDA approval · 2021-02-01FDA Approved: LANSOPRAZOLE — Original Application (NorthStar Rx LLC)
FDA approved NorthStar Rx LLC's Original Application for a generic lansoprazole. Lansoprazole is a proton pump inhibitor used to treat pepti…
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CLINICAL_TRIALS trial_result · 2021-01-15Clinical Trial Update: Correlates of GERD Symptom Severity
A completed clinical trial investigating correlates of gastroesophageal reflux disease symptom severity.
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CLINICAL_TRIALS trial_result · 2021-01-07Clinical Trial Update: Efficacy and Safety of DLBS2411 in the Management of GERD [Phase 3]
Phase 3 trial update for DLBS2411 in gastroesophageal reflux disease (GERD) evaluating efficacy and safety; study status terminated.
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CLINICAL_TRIALS trial_result · 2021-01-06Clinical Trial Update: The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers [Phase 3]
Phase 3 clinical trial evaluating the effect of a proton pump inhibitor in preventing gastroesophageal reflux disease among seafarers; curre…
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FDA approval · 2020-12-10FDA Approved: OMEPRAZOLE — Original Application (Golden State Medical Supply, Inc.)
FDA approved the original application for a generic omeprazole product (ANDA 212977) manufactured by Golden State Medical Supply, Inc.
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FDA approval · 2020-12-09FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Omeprazole from Dr. Reddy's Laboratories Limited.
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FDA approval · 2020-12-04FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) by Haleon US Holdings LLC. The approval concerns…
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CLINICAL_TRIALS trial_result · 2020-12-03Clinical Trial Update: Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study [NA]
Retrospective study update on TIF treatment for gastroesophageal reflux disease; the trial is terminated with results posted.
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FDA approval · 2020-12-01FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for generic omeprazole from Lannett Company under ANDA075410, authorizing continued marketing under …
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FDA approval · 2020-11-27FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Protonix delayed-release (pantoprazole sodium) submitted by Wyeth Pharmaceuticals LLC, a subsidi…
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FDA label_change · 2020-11-27FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the labeli…
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FDA approval · 2020-11-27FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID (lansoprazole) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2020-11-27FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for Omeprazole from Quallent Pharmaceuticals Health LLC (a generic proton pump inhibitor).
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FDA approval · 2020-11-27FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved Apotex Corp's supplemental application for omeprazole (generic), under ANDA076048.
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FDA approval · 2020-11-27FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc., related to a labeling/indica…