Zollinger-ellison Syndrome

• FDA approval · 2022-02-28
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for omeprazole from Apotex Corp, supporting a new generic entry for the product.

• FDA approval · 2021-11-14
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lansoprazole from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2021-11-09
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s supplemental application for lansoprazole (generic). This action approves a generic Lansoprazole produ…

• FDA approval · 2021-11-03
  FDA Approved: FAMOTIDINE — Original Application (Ascent Pharmaceuticals, Inc.)

  The FDA approves the original generic application for famotidine by Ascent Pharmaceuticals, Inc., enabling a generic version of this H2 bloc…

• FDA approval · 2021-10-15
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)

  The FDA approved a supplemental application for lansoprazole by Dr. Reddy's Laboratories Ltd. This approval updates the current marketing au…

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• FDA approval · 2021-10-15
  FDA Approved: FAMOTIDINE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved an original application for famotidine from XLCare Pharmaceuticals, Inc., marking the approval of a generic famotidine product.

• FDA approval · 2021-09-14
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for rabeprazole sodium (generic) from Ascend Laboratories, LLC.

• FDA approval · 2021-08-25
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2021-07-07
  FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

  FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole). This approval supports updates to labeling and expan…

• FDA approval · 2021-06-04
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Pantoprazole Sodium (Sun Pharmaceutical Industries, Inc.), resulting in updated labeling for…

• FDA approval · 2021-04-20
  FDA Approved: FAMOTIDINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' Original Application for famotidine, a generic H2 blocker, enabling marketing for ulcers and gastroeso…

• FDA approval · 2021-02-19
  FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for famotidine submitted by Chartwell RX, LLC (ANDA 075786). It authorizes changes to the approved g…

• CLINICAL_TRIALS trial_result · 2021-01-29
  Clinical Trial Update: YF476 and Type II Gastric Carcinoids [Phase 2]

  Phase 2 trial update for YF476 in Zollinger-Ellison Syndrome was terminated with results posted.

• 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 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: 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 (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 · 2020-11-13
  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…

• 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…

• 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.