Helicobacter Pylori Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-07-17FDA Approved: VOQUEZNA — Supplemental Application (Phathom Pharmaceuticals Inc.)
The FDA approved a supplemental application for VOQUEZNA (vonoprazan fumarate) filed by Phathom Pharmaceuticals. The action updates the prod…
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FDA approval · 2024-07-08FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)
FDA approved a supplemental application for the antibiotic combination Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochl…
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FDA approval · 2024-06-12FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for the fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin from Rising Pharma H…
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FDA approval · 2024-06-11FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for a generic fixed-dose combination of lansoprazole, amoxicillin, and clarithromycin. The product i…
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FDA approval · 2024-05-03FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for lansoprazole from Mylan Pharmaceuticals Inc., indicating an amendment to the approved generic pr…
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FDA approval · 2024-05-01FDA Approved: TALICIA — Supplemental Application (RedHill Biopharma Ltd)
The FDA approved a supplemental application for TALICIA, a fixed-dose combination of omeprazole magnesium, amoxicillin, and rifabutin develo…
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FDA approval · 2024-05-01FDA Approved: VOQUEZNA TRIPLE PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
The FDA approved a supplemental application for VOQUEZNA TRIPLE PAK (vonoprazan fumarate, amoxicillin, and clarithromycin). The approval exp…
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FDA approval · 2024-05-01FDA Approved: VOQUEZNA DUAL PAK — Supplemental Application (Phathom Pharmaceuticals Inc.)
FDA approved a supplemental application to authorize Voquezna Dual Pak, a fixed-dose combination of vonoprazan fumarate and amoxicillin, for…
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FDA approval · 2024-04-25FDA Approved: AMOXICILLIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for amoxicillin submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2024-02-23FDA Approved: LANSOPRAZOLE — Supplemental Application (Medcore LLC)
The FDA approved a supplemental application for Lansoprazole submitted by Medcore LLC. The snippet does not specify the exact changes covere…
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FDA approval · 2024-02-14FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for lansoprazole filed by Mylan Pharmaceuticals (ANDA 090763).
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FDA approval · 2024-02-05FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Esomeprazole Magnesium submitted by Zydus Pharmaceuticals USA Inc., enabling the generic esomepr…
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FDA approval · 2024-01-10FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Biocon Pharma Inc.,)
The FDA approved Biocon Pharma Inc.'s supplemental application for Esomeprazole Magnesium, a generic esomeprazole product, under ANDA 213486…
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EMA approval · 2023-12-04EMA Authorised: Pylobactell (urea (13C)) — Richen Europe S.R.L
Pylobactell, a urea-13C breath test product, has been authorised in Europe for use in breath testing and Helicobacter pylori infection asses…
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FDA approval · 2023-11-15FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for esomeprazole magnesium from Sun Pharmaceutical Industries, Inc. under an ANDA process, indicatin…
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FDA approval · 2023-11-14FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals' generic esomeprazole magnesium. This action confirms regulatory appr…
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FDA approval · 2023-11-08FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Esomeprazole Magnesium from Zydus Pharmaceuticals USA Inc., supporting its generic approval.
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FDA approval · 2023-11-01FDA Approved: VOQUEZNA — Original Application (Phathom Pharmaceuticals Inc.)
FDA approves Voquezna (vonoprazan fumarate) from Phathom Pharmaceuticals as an original application for the treatment of Helicobacter pylori…
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FDA approval · 2023-10-31FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Rabeprazole sodium submitted by Ascend Laboratories, LLC. This action approves the referenced ge…
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FDA approval · 2023-10-11FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting regulatory approval for changes to the generic product'…
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FDA approval · 2023-10-11FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
FDA approved a Supplemental Application for omeprazole by Sandoz Inc, confirming approval of a supplement to the Abbreviated New Drug Applic…
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FDA approval · 2023-10-05FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Esomeprazole Magnesium from Mylan Pharmaceuticals, making a generic version of the proton pump i…
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FDA approval · 2023-09-29FDA Approved: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — Original Application (MARKSANS PHARMA LIMITED)
FDA approved Marksans Pharma Limited's esomeprazole magnesium delayed-release capsules, 20 mg, as a generic therapeutic option for common ac…
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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…