Gastric Ulcer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2010-09-03FDA 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) from Wyeth Pharmaceuticals LLC (a Pfizer subs…
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FDA approval · 2010-09-03FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2010-09-03FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for Omeprazole and Sodium Bicarbonate.
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FDA approval · 2010-09-03FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…
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CLINICAL_TRIALS trial_result · 2010-08-20Clinical Trial Update: A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO) [Phase 3]
A 12-month, Phase 3 open-label study evaluated the long-term safety of Vimovo (naproxen/esomeprazole) for gastric ulcer; the trial has compl…
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FDA label_change · 2010-07-16FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a labeling supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen. The update m…
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FDA approval · 2010-07-15FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for famotidine from Alembic Pharmaceuticals Inc., adding approved changes to the product under the A…
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FDA approval · 2010-07-15FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories Limited's supplemental application for famotidine.
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CLINICAL_TRIALS trial_result · 2010-07-08Clinical Trial Update: Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer [Phase 3]
A Phase 3 randomized trial comparing esomeprazole 20 mg once daily with ranitidine 150 mg twice daily in NSAID-induced gastric ulcers; the s…
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FDA approval · 2010-06-29FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' original application for famotidine, a generic H2 blocker used for ulcers and GERD indications.
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CLINICAL_TRIALS trial_result · 2010-06-08Clinical Trial Update: Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets [NA]
An ongoing clinical trial update comparing ulcer healing in patients taking rabeprazole with different antiplatelets. The study covers gastr…
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CLINICAL_TRIALS trial_result · 2010-05-28Clinical Trial Update: Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID [Phase 3]
Phase 3 trial comparing esomeprazole with placebo for prevention of NSAID-associated gastric and duodenal ulcers; results completed and post…
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FDA approval · 2010-05-27FDA Approved: FAMOTIDINE — Original Application (Navinta LLC)
FDA approves Navinta LLC's original application for famotidine. This approval permits a generic version of famotidine to enter the market.
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FDA approval · 2010-04-30FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2010-03-04FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP. The approval update…
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FDA approval · 2010-01-20FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application to update the labeling for Omeprazole and Sodium Bicarbonate (Oceanside Pharmaceuticals).
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FDA approval · 2009-11-18FDA Approved: NIZATIDINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal's nizatidine original application (generic) for use in conditions treated by H2 blockers.
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FDA approval · 2009-11-10FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved an original ANDA for lansoprazole from Teva Pharmaceuticals USA, Inc., allowing a generic version of the proton pump inhibitor.…
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FDA approval · 2009-11-10FDA Approved: LANSOPRAZOLE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved Mylan Pharmaceuticals Inc.'s Original Application for a generic lansoprazole (Lansoprazole) under ANDA090763. Lansoprazole …
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CLINICAL_TRIALS trial_result · 2009-10-19Clinical Trial Update: Bioequivalence of Rebamipide in Korean [NA]
The study completed an evaluation of bioequivalence for Rebamipide in Korean subjects, addressing therapeutic equivalence and pharmacogeneti…
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FDA approval · 2009-09-21FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole). This action typically updates labeling, manu…
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FDA approval · 2009-07-31FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add the Solutab dosage form to the approved product line. The…
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CLINICAL_TRIALS research · 2009-06-25Clinical Trial Update: H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection [Phase 4]
A Phase 4 clinical trial update examining whether eradicating Helicobacter pylori enhances healing of iatrogenic gastric ulcers after endosc…
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FDA approval · 2009-06-18FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the la…
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FDA label_change · 2009-05-28FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)
The FDA approved a supplemental application for ranitidine from Pharmaceutical Associates, Inc., indicating a labeling or related change to …