Duodenal Ulcer

• FDA approval · 2022-03-04
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) by Waylis Therapeutics LLC. The snippet does not specify the ex…

• FDA approval · 2022-03-04
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Omeprazole submitted by Apotex Corp.

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for omeprazole submitted by Zydus Lifesciences Limited. The exact scope of the supplement (such as l…

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for a generic omeprazole product from Lannett Company, Inc.

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• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for omeprazole, a generic proton pump inhibitor, expanding or updating its approval for…

• FDA approval · 2022-03-04
  FDA Approved: LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic triple-drug regimen of lansoprazole, amoxicillin, and clarithromycin (manufactured by …

• FDA approval · 2022-03-04
  FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' Omeprazole, a generic proton pump inhibitor, under the ANDA process.

• 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 · 2022-01-28
  FDA Approved: CURIST ACID RELIEF — Original Application (Little Pharma, Inc.)

  The FDA approved CURIST ACID RELIEF, a 20 mg famotidine tablet from Little Pharma, Inc., under an original ANDA.

• FDA approval · 2022-01-07
  FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for famotidine, establishing a new generic entry for the acid-reducing medication…

• 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 · 2021-11-12
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Camber Pharmaceuticals' lansoprazole, a generic proton pump inhibitor, under ANDA 203083.

• 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 · 2021-10-21
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) manufactured by AmerisourceBergen.

• 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…

• 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 · 2021-08-30
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic rabeprazole sodium product from Aurobindo Pharma Limited.

• FDA approval · 2021-07-26
  FDA Tentative Approval: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  The FDA issued tentative approval for Civica, Inc.'s pantoprazole sodium supplemental application (NDA 209463), enabling tentative U.S. mark…

• FDA approval · 2021-07-20
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• 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…

• CLINICAL_TRIALS trial_result · 2021-05-19
  Clinical Trial Update: Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

  Completed long-term surveillance trial evaluating vonoprazan for prevention of recurrence of gastric/duodenal ulcers in NSAID users; results…

• 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…