Peptic Ulcer Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-06-25FDA Approved: ACID REDUCER — Original Application (CVS Pharmacy)
The FDA approved CVS Pharmacy's original application for a generic esomeprazole magnesium product (ACID REDUCER), expanding access to proton…
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CLINICAL_TRIALS trial_result · 2020-06-23Clinical Trial Update: Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis [Phase 2, Phase 3]
A combined therapy of a proton pump inhibitor with propranolol was studied against PPI alone for healing peptic ulcers in patients with live…
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FDA label_change · 2020-05-13FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)
FDA approved a supplemental application for famotidine (Carlsbad Technology, Inc.), resulting in changes to its labeling.
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FDA approval · 2020-05-04FDA Approved: ESOMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)
FDA approved Innovus Pharmaceuticals' original application for esomeprazole magnesium (Esomeprazole), a generic formulation.
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FDA approval · 2020-03-03FDA Approved: LANSOPRAZOLE — Supplemental Application (Lifestar Pharma LLC.)
FDA approves a supplemental application to allow Lifestar Pharma LLC to market a generic version of lansoprazole.
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FDA approval · 2020-02-21FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)
The FDA approved a supplemental application for Walgreens' CIMETIDINE 200 ACID REDUCER, indicating approval of changes to the approved gener…
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CLINICAL_TRIALS trial_result · 2020-02-17Clinical Trial Update: Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB) [Phase 4]
Phase 4 trial comparing oral vs intravenous administration and PPI for peptic ulcer bleeding has been withdrawn.
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FDA approval · 2020-01-03FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium from Lannett Company (ANDA 078281).
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FDA approval · 2019-12-02FDA Approved: SUCRALFATE — Original Application (AvPAK)
FDA approved the original ANDA for sucralfate oral, enabling generic marketing by AvPAK.
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FDA approval · 2019-11-01FDA Approved: TALICIA — Original Application (RedHill Biopharma Ltd)
FDA approved TALICIA, a fixed-dose combination of omeprazole magnesium, amoxicillin, and rifabutin, for Helicobacter pylori infection. The a…
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FDA approval · 2019-10-22FDA Approved: FAMOTIDINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for famotidine by Aurobindo Pharma Limited under an ANDA, extending approval to include this manufac…
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FDA approval · 2019-09-24FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for OMEPRAZOLE AND SODIUM BICARBONATE (omeprazole and sodium bicarbonate) from Oceanside Pharmaceuti…
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FDA approval · 2019-08-19FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Pantoprazole Sodium as an original generic application from Sun Pharmaceutical Industries, Inc.
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CLINICAL_TRIALS trial_result · 2019-08-08Clinical Trial Update: Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers [NA]
A completed clinical trial comparing a proton pump inhibitor to a histamine-2 receptor antagonist for preventing recurrent peptic ulcers; re…
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CLINICAL_TRIALS trial_result · 2019-08-01Clinical Trial Update: PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers [Phase 4]
Phase 4 trial comparing proton pump inhibitors to H2 receptor antagonists in Helicobacter pylori–negative idiopathic bleeding ulcers; study …
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FDA approval · 2019-07-01FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for lansoprazole from Teva Pharmaceuticals USA, Inc. for the generic product under the ANDA process.
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FDA approval · 2019-05-10FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's original generic application for esomeprazole magnesium, authorizing its use as a proton pump inhibitor. The pro…
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FDA approval · 2019-05-10FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)
The FDA approved a supplemental application for Lansoprazole from Dr. Reddy's Laboratories Ltd., approving the generic product update.
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FDA approval · 2019-04-25FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to add intravenous pantoprazole sodium (PROTONIX I.V.) as a new dosage form for the drug, expand…
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FDA approval · 2019-04-25FDA 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) from Wyeth Pharmaceuticals (a Pfizer subsidiary).
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FDA approval · 2019-03-26FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)
FDA approved a supplemental application for Tagamet (cimetidine) from Prestige Brands Holdings, Inc., resulting in an updated product labeli…
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FDA approval · 2019-02-01FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for rabeprazole sodium (generic) submitted by Aurobindo Pharma Limited. This confirms an approve…
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CLINICAL_TRIALS research · 2019-02-01Clinical Trial Update: Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB) [NA]
A completed clinical trial comparing urgent versus early endoscopy in high-risk patients with upper gastrointestinal bleeding due to peptic …
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FDA approval · 2018-11-05FDA Approved: OMEPRAZOLE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for a generic omeprazole product. Omeprazole is a proton pump inhibitor indicated for gas…
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FDA approval · 2018-10-05FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the combination of bismuth subitrate potassium, metronidazole, and tetracycline hydrochloride (H…