Erosive Esophagitis

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-01-20
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca, updating the labeling under a supplemental…

• FDA approval · 2012-01-17
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Pantoprazole Sodium by Torrent Pharmaceuticals Limited. The approval denotes changes under a sup…

• FDA approval · 2012-01-17
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium by Lannett Company, Inc., authorizing the continued market approval of a gen…

• CLINICAL_TRIALS trial_result · 2012-01-12
  Clinical Trial Update: Efficacy Study of Ilaprazole to Treat Erosive Esophgitis [Phase 3]

  Phase 3 efficacy study of ilaprazole for erosive esophagitis and GERD has completed.

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• FDA approval · 2012-01-11
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for pantoprazole submitted by NorthStar RxLLC.

• FDA approval · 2011-12-15
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Nexium (esomeprazole magnesium) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2011-12-07
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Oceanside Pharmaceuticals' omeprazole and sodium bicarbonate, updating labeling through a supple…

• FDA approval · 2011-12-07
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application to authorize the intravenous form of Protonix (pantoprazole sodium) from Wyeth Pharmaceuticals (Pfiz…

• FDA approval · 2011-10-31
  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) from Wyeth Pharmaceuticals (Pfizer).

• FDA approval · 2011-10-28
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The action…

• FDA approval · 2011-10-28
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc.

• FDA label_change · 2011-06-17
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda, resulting in changes to the drug’s labeling.

• FDA approval · 2011-06-07
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application to authorize the intravenous formulation of Protonix (pantoprazole sodium) from Wyeth Pharmaceut…

• FDA approval · 2011-06-01
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID SOLUTAB (lansoprazole) to add a Solutab formulation, submitted by Takeda Pharmaceut…

• FDA label_change · 2011-05-20
  FDA 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 update the product labeling.

• FDA approval · 2011-05-20
  FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application to add the intravenous formulation of PROTONIX (pantoprazole sodium) from Wyeth Pharmaceuticals …

• FDA label_change · 2011-05-20
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC to update the product labeling…

• FDA approval · 2011-05-20
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Omeprazole and Sodium Bicarbonate from Oceanside Pharmaceuticals, updating the labeling to refle…

• FDA approval · 2011-05-20
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-01-20
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)

  FDA approved Lannett Company's original Abbreviated New Drug Application for pantoprazole sodium, enabling a generic pantoprazole product. T…

• FDA approval · 2011-01-19
  FDA Approved: PANTOPRAZOLE — Original Application (NorthStar RxLLC)

  FDA approved the original application for pantoprazole submitted by NorthStar RxLLC, launching a generic pantoprazole product.

• FDA approval · 2011-01-19
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Pantoprazole sodium from Torrent Pharmaceuticals Limited under an original ANDA; a generic version of pantoprazole for conditio…

• FDA approval · 2011-01-19
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original ANDA for pantoprazole sodium, a generic proton pump inhibitor manufactured by Mylan Pharmaceuticals. This approval…

• FDA approval · 2011-01-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc., granting an additional approval under the ANDA for the generic …