Gastric Ulcer

• FDA approval · 2007-04-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, resulting in updated labeling.

• FDA approval · 2007-04-26
  FDA Approved: SUCRALFATE — Supplemental Application (Mylan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for sucralfate from Mylan Pharmaceuticals, Inc., indicating an approved modification to the prod…

• FDA approval · 2007-04-26
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CARAFATE (sucralfate) from Allergan, Inc., resulting in updated labeling and/or indication infor…

• FDA approval · 2007-03-21
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for omeprazole by Sandoz Inc. This action updates the current approval for this generic drug.

• FDA approval · 2007-03-16
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for cimetidine, approving changes to its labeling/indication. This update broadens or clarifies…

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• FDA approval · 2006-10-20
  FDA Approved: NEXIUM — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Nexium (esomeprazole magnesium) as AstraZeneca's original NDA. The approval established Nexium as a proton pump inhibitor for a…

• FDA approval · 2006-10-13
  FDA Approved: RANITIDINE — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's original application for generic ranitidine, authorizing its commercial ranitidine…

• FDA approval · 2006-09-26
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole from Lannett Company, Inc., enabling the marketing of the generic omeprazole product.

• FDA approval · 2006-09-25
  FDA Approved: FAMOTIDINE — Original Application (Chain Drug Consortium, LLC)

  The FDA approved Chain Drug Consortium, LLC's original application for famotidine, enabling a generic version of famotidine to be marketed. …

• FDA approval · 2006-09-25
  FDA Approved: ACID RELIEF — Original Application (Rite Aid Corporation)

  The FDA approved ACID RELIEF (famotidine) from Rite Aid under an Original Application (ANDA), making a generic famotidine product available.

• CLINICAL_TRIALS research · 2006-09-11
  Clinical Trial Update: Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori [Phase 3]

  Phase 3 clinical trial evaluating a tailored treatment strategy for Helicobacter pylori infection based on CYP2C19 and 23S rRNA polymorphism…

• FDA approval · 2006-07-25
  FDA 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) submitted by Wyeth Pharmaceuticals LLC, a sub…

• FDA approval · 2006-06-09
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) by Kenvue Brands LLC, supporting a higher-strength formu…