Duodenal Ulcer
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2012-12-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (lansoprazole) filed by Takeda, extending its labeling with additional indications.
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FDA approval · 2012-12-19FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., signaling an approved modification to the produc…
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FDA approval · 2012-12-17FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approves Lupin Pharmaceuticals' famotidine as a generic product under an original ANDA, authorizing its marketing for approved indicatio…
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FDA approval · 2012-12-12FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for famotidine filed by Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2012-11-22Clinical Trial Update: Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin [Phase 3]
Phase 3 trial comparing D961H to placebo for the prevention of gastric and duodenal ulcers in users of low-dose aspirin; results have been p…
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FDA approval · 2012-11-13FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for cimetidine, resulting in an expanded label/approval for the drug.
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FDA approval · 2012-11-09FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved Oceanside Pharmaceuticals' supplemental application for the fixed-dose combination of omeprazole and sodium bicarbonate, with u…
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FDA approval · 2012-11-02FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for omeprazole submitted by Lannett Company, Inc. The approval pertains to a change to the marketed …
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FDA approval · 2012-10-09FDA 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 modify/expand its labeling.
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FDA approval · 2012-10-09FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc, indicating an approved update to the la…
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FDA approval · 2012-10-05FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.
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FDA approval · 2012-09-28FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2012-09-28FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Prevacid Solutab (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2012-09-14Clinical Trial Update: Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer [Phase 3]
Phase 3 long-term study assessing the efficacy and safety of D961H esomeprazole for preventing NSAID-induced ulcers; the trial has completed…
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FDA approval · 2012-09-10FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for GOOD NEIGHBOR PHARMACY OMEPRAZOLE (omeprazole) under NDA 022032, with Amerisource Bergen as the …
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FDA approval · 2012-08-27FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals under ANDA078878, approving the changes describ…
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FDA approval · 2012-06-13FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)
FDA approved a supplemental application for famotidine from Carlsbad Technology, Inc.
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FDA label_change · 2012-05-18FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Pantoprazole Sodium (Lannett Company) under ANDA 078281, signaling changes to the labeling f…
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FDA approval · 2012-05-18FDA Approved: BASIC CARE LANSOPRAZOLE — Original Application (Amazon.com Services LLC)
FDA approved a generic lansoprazole product, BASIC CARE LANSOPRAZOLE, under an original application by Amazon.com Services LLC. This provide…
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FDA approval · 2012-05-18FDA Approved: LANSOPRAZOLE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original ANDA for lansoprazole from Dr. Reddy's Laboratories, authorizing a generic lansoprazole product.
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FDA approval · 2012-05-11FDA 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 (Pfizer).
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FDA approval · 2012-05-10FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for PROTONIX I.V. (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfizer).
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FDA approval · 2012-05-08FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved Waylis Therapeutics LLC's supplemental application for ACIPHEX (rabeprazole sodium).
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FDA approval · 2012-04-19FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for an omeprazole and sodium bicarbonate product, updating its labeling…
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FDA approval · 2012-04-18FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for lansoprazole, authorizing the marketing of a generic lansoprazole…