Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for pantoprazole by NorthStar RxLLC under ANDA077619.
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FDA approval · 2023-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Lannett Company, Inc., approving changes to the product's labeling relate…
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CLINICAL_TRIALS trial_result · 2023-09-26Clinical Trial Update: A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection [Phase 4]
Phase 4 clinical trial comparing concomitant versus load therapy for eradication of Helicobacter pylori completed.
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CLINICAL_TRIALS trial_result · 2023-09-26Clinical Trial Update: Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice [Phase 4]
Phase 4 clinical trial comparing sequential and concomitant therapy for Helicobacter pylori eradication completed in routine clinical practi…
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FDA approval · 2023-09-11FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for esomeprazole magnesium submitted by Cipla USA Inc.
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CLINICAL_TRIALS trial_result · 2023-09-07Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection [Phase 3]
Phase 3 trial evaluating bismuth-containing quadruple therapy with vonoprazan vs esomeprazole for Helicobacter pylori infection has complete…
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CLINICAL_TRIALS trial_result · 2023-08-31Clinical Trial Update: A Study of Vonoprazan in Adults With Helicobacter Pylori [Phase 1]
Phase 1 trial evaluating vonoprazan in adults with Helicobacter pylori has completed with results posted.
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FDA approval · 2023-08-16FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for clarithromycin, marking a supplemental approval for this generic antibiotic. The acti…
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FDA approval · 2023-08-16FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a combination tablet containing lansoprazole, amoxicillin, and clarithromycin (Rising Pharma Hol…
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FDA approval · 2023-08-16FDA Approved: CLARITHROMYCIN — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic version of clarithromycin produced by Lannett Company, Inc.
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FDA approval · 2023-08-16FDA Approved: VOQUEZNA DUAL PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
The FDA approved a supplemental application for Voquezna Dual Pak (vonoprazan fumarate and amoxicillin) from Phathom Pharmaceuticals.
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FDA approval · 2023-08-16FDA Approved: VOQUEZNA TRIPLE PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
FDA approves a supplemental application for Voquezna Triple Pak (vonoprazan, amoxicillin, and clarithromycin) from Phathom Pharmaceuticals.
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FDA approval · 2023-08-08FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID SOLUTAB to include the lansoprazole Solutab formulation from Takeda Pharmaceuticals Ame…
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CLINICAL_TRIALS trial_result · 2023-08-07Clinical Trial Update: Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy [Phase 4]
Phase 4 clinical trial comparing vonoprazan-based triple therapy to extended sequential therapy for Helicobacter pylori infection.
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CLINICAL_TRIALS trial_result · 2023-07-19Clinical Trial Update: Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication [Phase 4]
Phase 4 trial update on bismuth-containing quadruple therapy for Helicobacter pylori eradication is completed.
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FDA approval · 2023-07-18FDA 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 · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
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FDA approval · 2023-07-18FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA granted supplemental approval for a lansoprazole-amoxicillin-clarithromycin combination product by Rising Pharma Holdings, Inc. to e…
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FDA label_change · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for omeprazole, resulting in updated labeling for the product. This is a s…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole by Aurobindo Pharma Limited. The action provides regulatory clearance for the generic…
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FDA approval · 2023-07-12FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Aurohealth LLC)
FDA approved esomeprazole magnesium as a generic drug from Aurohealth LLC under ANDA 214473.
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CLINICAL_TRIALS trial_result · 2023-07-06Clinical Trial Update: Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients [Phase 2]
Exploratory Phase 2 trial evaluating standard triple therapy including tegoprazan in Helicobacter pylori–positive patients.
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FDA approval · 2023-07-03FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for a fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochl…
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FDA approval · 2023-06-07FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for esomeprazole magnesium (generic) from Zydus Pharmaceuticals USA Inc. The approval covers the same …
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries' supplemental application for esomeprazole magnesium (generic), a proton pump inhibitor, under th…