Gastric Ulcer
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2015-01-01Clinical Trial Update: Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole [Phase 1]
Phase 1 study evaluating how CYP2C19 genetic variants influence the pharmacokinetics and pharmacodynamics of omeprazole in gastric ulcer pat…
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FDA approval · 2014-12-21FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application for pantoprazole submitted by NorthStar RxLLC under the ANDA pathway.
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FDA approval · 2014-12-19FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2014-12-19FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-12-19FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)
FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC, granting approval of this salt form under NDA 202342…
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FDA approval · 2014-12-19FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-12-19FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) submitted by Wyeth Pharmaceuticals (Pfizer). …
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FDA approval · 2014-12-10FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Pantoprazole Sodium from Lannett Company, Inc., confirming the generic version of this product.
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FDA approval · 2014-12-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited, marking an update to the product's app…
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing continued manufacture and sale of a generic omeprazole p…
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FDA approval · 2014-10-31FDA Approved: OMEPRAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's generic omeprazole, establishing bioequivalence to the reference product and authorizing its marketing in the United…
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FDA label_change · 2014-10-15FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the labeling.
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FDA approval · 2014-09-26FDA Approved: TAGAMET — Supplemental Application (Prestige Brands Holdings, Inc.)
The FDA approved a supplemental application for Tagamet (cimetidine) filed by Prestige Brands Holdings, Inc., likely resulting in labeling c…
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FDA approval · 2014-09-10FDA Approved: PANTOPRAZOLE SODIUM — Original Application (XLCare Pharmaceuticals Inc.)
FDA approves the original abbreviated new drug application for pantoprazole sodium, enabling a generic pantoprazole product from XLCare Phar…
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FDA approval · 2014-08-05FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc. under an ANDA.
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CLINICAL_TRIALS trial_result · 2014-05-30Clinical Trial Update: A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers [Phase 1]
A Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 in healthy male volunteers has b…
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FDA approval · 2014-05-30FDA Approved: FAMOTIDINE — Original Application (Akorn)
The FDA approved Akorn's original application for a generic famotidine product, enabling market entry of a competitor to the brand-name drug…
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FDA approval · 2014-05-28FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the combination drug bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride,…
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CLINICAL_TRIALS trial_result · 2014-04-16Clinical Trial Update: Nexium Capsules Clinical Experience Investigation
Nexium (esomeprazole) capsules completed a clinical experience investigation. The study covered gastric and duodenal ulcers, anastomotic ulc…
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CLINICAL_TRIALS trial_result · 2014-04-16Clinical Trial Update: Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation
A completed trial update evaluating Nexium (esomeprazole) for Helicobacter pylori–specific clinical experience across several gastric diseas…
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CLINICAL_TRIALS trial_result · 2014-04-09Clinical Trial Update: Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding [NA]
An update on a clinical trial evaluating the efficacy and safety of L-Pantoprazole Sodium Injection for upper gastrointestinal ulcer bleedin…
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FDA approval · 2014-02-25FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…
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FDA approval · 2014-02-14FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals, updating the approval status for this generic …
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CLINICAL_TRIALS other · 2014-02-11Clinical Trial Update: Concomitant Therapy of H. Pylori [Phase 4]
A Phase 4 clinical trial update for concomitant Helicobacter pylori therapy in gastritis and peptic ulcers; current status is UNKNOWN.
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CLINICAL_TRIALS trial_result · 2014-02-10Clinical Trial Update: A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy [Phase 3]
This Phase 3 unblinded trial evaluated TAK-438 (20 mg) for preventing recurrence of gastric or duodenal ulcers in patients on long-term low-…