Erosive Esophagitis

• FDA approval · 2020-12-09
  FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Omeprazole from Dr. Reddy's Laboratories Limited.

• FDA approval · 2020-12-01
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for generic omeprazole from Lannett Company under ANDA075410, authorizing continued marketing under …

• FDA approval · 2020-11-27
  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) submitted by Wyeth Pharmaceuticals LLC, a subsidi…

• FDA label_change · 2020-11-27
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP to update the labeli…

• FDA approval · 2020-11-27
  FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PREVACID (lansoprazole) from Takeda Pharmaceuticals America, Inc.

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• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Omeprazole from Quallent Pharmaceuticals Health LLC (a generic proton pump inhibitor).

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved Apotex Corp's supplemental application for omeprazole (generic), under ANDA076048.

• FDA approval · 2020-11-27
  FDA Approved: ESOMEPRAZOLE STRONTIUM — Supplemental Application (R2 Pharma, LLC)

  The FDA approved a supplemental application for esomeprazole strontium from R2 Pharma, LLC. This action authorizes the salt form of esomepra…

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for omeprazole from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for omeprazole submitted by Aurobindo Pharma Limited (ANDA 203270), granting approval for a generi…

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc (ANDA075757). The approval confirms the generic product under the app…

• FDA approval · 2020-11-27
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Pantoprazole Sodium from Civica, Inc. (AP submission).

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' generic omeprazole.

• FDA approval · 2020-11-27
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited, authorizing a generic omeprazole product. The ap…

• FDA approval · 2020-11-20
  FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)

  FDA approved a supplemental application for EQUATE LANSOPRAZOLE (lansoprazole) from Wal-Mart Stores Inc.

• FDA approval · 2020-11-16
  FDA Approved: OMEPRAZOLE — Supplemental Application (OHM LABORATORIES INC.)

  FDA approved a supplemental application for Omeprazole from OHM Laboratories Inc., resulting in an updated approval for the generic product.

• FDA approval · 2020-11-13
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole) under the BJWC label, allowing continued marketing wi…

• FDA approval · 2020-10-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s esomeprazole magnesium as a generic product under an ANDA to treat acid-related disorders, inclu…

• CLINICAL_TRIALS trial_result · 2020-09-16
  Clinical Trial Update: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients [Phase 3]

  A Phase III randomized, double-blind trial comparing Lafutidine, Famotidine, and Omeprazole in Korean patients with erosive esophagitis. The…

• FDA approval · 2020-09-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for famotidine from Mylan Institutional LLC.

• FDA approval · 2020-09-11
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Prevacid Solutab (lansoprazole) from Takeda Pharmaceuticals America, Inc., related to the So…

• CLINICAL_TRIALS trial_result · 2020-09-03
  Clinical Trial Update: Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3) [Phase 3]

  Phase 3 trial evaluating DWP14012 for erosive esophagitis has completed.

• CLINICAL_TRIALS trial_result · 2020-09-03
  Clinical Trial Update: Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis [Phase 3]

  Phase 3 study evaluating DWP14012 for maintaining healing in subjects with healed erosive esophagitis is ongoing; no results or status discl…

• FDA approval · 2020-08-20
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Xiromed LLC)

  FDA approved a supplemental application for lansoprazole by Xiromed LLC, indicating an approved update to an already-approved product (such …

• FDA approval · 2020-06-30
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Pantoprazole sodium as a generic pantoprazole product under an original application by Sun Pharmaceutical Industries, Inc.