Gastric Ulcer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2011-10-28FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The action…
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FDA approval · 2011-07-31FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for nizatidine from Epic Pharma, LLC (ANDA 076178). This marks approval of a supplemental update for…
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FDA approval · 2011-06-07FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to authorize the intravenous formulation of Protonix (pantoprazole sodium) from Wyeth Pharmaceut…
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FDA approval · 2011-06-01FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add a Solutab formulation, submitted by Takeda Pharmaceut…
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FDA label_change · 2011-05-20FDA 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/Pfizer to update the product labeling.
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FDA label_change · 2011-05-20FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the product labeling…
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CLINICAL_TRIALS trial_result · 2011-05-19Clinical Trial Update: Safety of Rabeprazole in Patients Under Multiple Treatments
A terminated clinical trial evaluating the safety of rabeprazole in patients receiving multiple concomitant treatments for gastroesophageal …
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CLINICAL_TRIALS trial_result · 2011-05-10Clinical Trial Update: Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs [Phase 3]
Phase 3 trial evaluating the efficacy and safety of lansoprazole for NSAID-associated gastric and duodenal ulcers, with results posted.
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CLINICAL_TRIALS trial_result · 2011-05-10Clinical Trial Update: Pharmacogenetics of Gastrointestinal Bleeding
A completed clinical trial update on the pharmacogenetics of gastrointestinal bleeding. The study addresses conditions including gastrointes…
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CLINICAL_TRIALS trial_result · 2011-05-10Clinical Trial Update: A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers [Phase 3]
Phase 3 trial evaluating lansoprazole to prevent aspirin-induced gastric and duodenal ulcers was terminated; results have been posted.
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CLINICAL_TRIALS research · 2011-03-03Clinical Trial Update: Efficacy of Ecabet Sodium and Proton Pump Inhibitor Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection [Phase 4]
Phase 4 study evaluating whether combining ecabet sodium with a proton pump inhibitor improves healing of iatrogenic gastric ulcers after en…
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CLINICAL_TRIALS trial_result · 2011-01-24Clinical Trial Update: An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium [Phase 4]
The document reports the completion of a Phase 4 open-label exploratory trial evaluating gastric acid control in critically ill patients tre…
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FDA approval · 2011-01-20FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)
FDA approved Lannett Company's original Abbreviated New Drug Application for pantoprazole sodium, enabling a generic pantoprazole product. T…
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FDA approval · 2011-01-19FDA Approved: PANTOPRAZOLE — Original Application (NorthStar RxLLC)
FDA approved the original application for pantoprazole submitted by NorthStar RxLLC, launching a generic pantoprazole product.
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FDA approval · 2011-01-07FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc., granting an additional approval under the ANDA for the generic …
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FDA approval · 2011-01-06FDA Approved: FAMOTIDINE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for famotidine submitted by Baxter Healthcare Corporation, resulting in a label change for the produ…
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CLINICAL_TRIALS trial_result · 2010-12-28Clinical Trial Update: Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen [Phase 3]
Phase 3 trial comparing VIMOVO (naproxen/esomeprazole) to naproxen for reducing gastric ulcers; results posted.
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CLINICAL_TRIALS trial_result · 2010-12-28Clinical Trial Update: Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen [Phase 3]
A Phase 3 trial evaluated Vimovo (naproxen with esomeprazole) for reducing gastric ulcers compared with naproxen alone; the study has comple…
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FDA approval · 2010-12-21FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for Carafate (sucralfate) submitted by Allergan, Inc.
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FDA approval · 2010-11-23FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting approval for this generic proton pump inhibitor under an AN…
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FDA approval · 2010-11-17FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for the generic omeprazole from Lannett Company, Inc., authorizing continued marketing under the…
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FDA approval · 2010-10-29FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …
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FDA approval · 2010-10-27FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)
The FDA approved a supplemental application for ranitidine submitted by Pharmaceutical Associates, Inc. The approval updates the product's e…
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CLINICAL_TRIALS withdrawal · 2010-10-22Clinical Trial Update: Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer
A clinical trial investigating a gastroprotective agent for patients at risk with a gastrointestinal ulcer has been withdrawn.
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CLINICAL_TRIALS trial_result · 2010-09-22Clinical Trial Update: Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec [Phase 3]
Phase 3 trial update evaluating Vimovo (naproxen/esomeprazole) for reducing gastric ulcers in high-risk subjects compared with Arthrotec. Th…