Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2022-12-02Clinical Trial Update: Optimized-dose Amoxicillin Versus Standard-dose Amoxicillin for Quadruple Therapy in Helicobacter Pylori Eradication [Phase 4]
Phase 4 trial comparing an optimized-dose amoxicillin regimen to standard-dose amoxicillin within quadruple therapy for Helicobacter pylori …
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CLINICAL_TRIALS trial_result · 2022-11-29Clinical Trial Update: A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection [Phase 4]
A Phase 4 randomized trial evaluating the efficacy of vonoprazan 20 mg once daily for Helicobacter pylori infection.
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CLINICAL_TRIALS trial_result · 2022-10-20Clinical Trial Update: Vonoprazan Hp Dual or Triple Eradication Regimes [Phase 4]
A Phase 4 clinical trial update evaluating vonoprazan-based dual or triple eradication regimens for Helicobacter pylori infection.
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FDA label_change · 2022-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for pantoprazole sodium from Sun Pharmaceutical Industries, resulting in an updated labeling for the…
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FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Rabeprazole sodium submitted by Aurobindo Pharma Limited.
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FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for rabeprazole sodium (Ascend Laboratories, LLC). This indicates regulatory approval of the generic…
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FDA approval · 2022-08-29FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Northstar Rx LLC)
FDA approved Pantoprazole sodium as an original ANDA for a generic product manufactured by Northstar Rx LLC.
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CLINICAL_TRIALS withdrawal · 2022-08-05Clinical Trial Update: Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole [Phase 4]
A Phase 4 trial evaluating the effect of food on eradication rates of Helicobacter pylori with triple therapy including esomeprazole has bee…
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CLINICAL_TRIALS trial_result · 2022-08-02Clinical Trial Update: A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection [Phase 2]
Phase 2 clinical trial evaluating the efficacy of gastric probiotics for Helicobacter pylori infection.
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CLINICAL_TRIALS trial_result · 2022-07-12Clinical Trial Update: Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications [Phase 4]
Phase 4 trial assessing adverse events related to Helicobacter pylori eradication medications in patients with H. pylori infection.
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FDA approval · 2022-06-24FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original ANDA for esomeprazole magnesium as a generic proton pump inhibitor manufactured by Rising Pharma Holdings, Inc.
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CLINICAL_TRIALS trial_result · 2022-06-08Clinical Trial Update: Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP [Phase 3]
A Phase 3 clinical trial comparing levofloxacin sequential therapy to quadruple therapy as second-line treatment for Helicobacter pylori inf…
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CLINICAL_TRIALS trial_result · 2022-05-17Clinical Trial Update: Helicobacter Eradication Aspirin Trial [Phase 4]
Phase 4 clinical trial update on Helicobacter eradication in the context of gastrointestinal ulcer hemorrhage and H. pylori infection has co…
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FDA approval · 2022-05-03FDA Approved: VOQUEZNA DUAL PAK — Original Application (Phathom Pharmaceuticals Inc.)
FDA approved Voquezna Dual Pak (vonoprazan fumarate and amoxicillin) from Phathom Pharmaceuticals for eradication of Helicobacter pylori inf…
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FDA approval · 2022-05-03FDA Approved: VOQUEZNA TRIPLE PAK — Original Application (Phathom Pharmaceuticals Inc.)
The FDA approved Voquezna Triple Pak, a combination therapy of vonoprazan fumarate, amoxicillin, and clarithromycin, for the treatment of He…
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FDA approval · 2022-04-14FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application to market a generic fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin for Heli…
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CLINICAL_TRIALS trial_result · 2022-04-05Clinical Trial Update: Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection [Phase 3]
Phase 3 trial comparing vonoprazan to lansoprazole for Helicobacter pylori infection completed with posted results.
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CLINICAL_TRIALS trial_result · 2022-03-18Clinical Trial Update: Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment [Phase 4]
Phase 4 clinical trial update evaluating susceptibility-guided therapy for Helicobacter pylori infection.
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FDA approval · 2022-03-16FDA Approved: METRONIDAZOLE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for METRONIDAZOLE submitted by Prasco Laboratories.
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Omeprazole submitted by Apotex Corp.
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for omeprazole submitted by Zydus Lifesciences Limited. The exact scope of the supplement (such as l…
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FDA approval · 2022-03-04FDA Approved: TALICIA — Supplemental Application (RedHill Biopharma Ltd)
The FDA approved a supplemental application for TALICIA (omeprazole magnesium, amoxicillin and rifabutin) from RedHill Biopharma Ltd.
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's supplemental application for omeprazole, a generic proton pump inhibitor, expanding or updating its approval for…
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FDA approval · 2022-03-04FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a generic triple-drug regimen of lansoprazole, amoxicillin, and clarithromycin (manufactured by …
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FDA approval · 2022-03-04FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' Omeprazole, a generic proton pump inhibitor, under the ANDA process.