Erosive Esophagitis

• FDA approval · 2020-06-25
  FDA Approved: ACID REDUCER — Original Application (CVS Pharmacy)

  The FDA approved CVS Pharmacy's original application for a generic esomeprazole magnesium product (ACID REDUCER), expanding access to proton…

• FDA approval · 2020-06-23
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for pantoprazole sodium submitted by Civica, Inc. with this action representing an approved supp…

• FDA approval · 2020-06-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' esomeprazole magnesium as a generic product (Original Application), expanding access to a proton pump i…

• FDA approval · 2020-06-02
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Allegiant Health)

  FDA approved Allegiant Health's esomeprazole magnesium delayed-release capsule as an original ANDA, providing a generic proton pump inhibito…

• FDA approval · 2020-05-18
  FDA Approved: LANSOPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic lansoprazole product.

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• FDA approval · 2020-05-14
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved an original-application generic esomeprazole magnesium from Dr. Reddy's Laboratories Inc.

• FDA label_change · 2020-05-13
  FDA Approved: FAMOTIDINE — Supplemental Application (Carlsbad Technology, Inc)

  FDA approved a supplemental application for famotidine (Carlsbad Technology, Inc.), resulting in changes to its labeling.

• FDA approval · 2020-05-04
  FDA Approved: ESOMEPRAZOLE — Original Application (INNOVUS PHARMACEUTICALS, INC.)

  FDA approved Innovus Pharmaceuticals' original application for esomeprazole magnesium (Esomeprazole), a generic formulation.

• FDA approval · 2020-04-30
  FDA Approved: OMEPRAZOLE, SODIUM BICARBONATE — Original Application (Guardian Drug Company)

  FDA approved Guardian Drug Company's original application for omeprazole sodium bicarbonate, a generic proton pump inhibitor combination, fo…

• FDA approval · 2020-04-20
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for esomeprazole magnesium (Ascend Laboratories) to bring a generic product to market.

• CLINICAL_TRIALS trial_result · 2020-04-15
  Clinical Trial Update: Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis [Phase 3]

  Phase 3 trial comparing LXI-15028 with esomeprazole for erosive esophagitis has completed.

• FDA approval · 2020-04-01
  FDA Approved: ESOMEPRAZOLE SODIUM — Original Application (Gland Pharma Limited)

  FDA approved the original application for esomeprazole sodium (generic) from Gland Pharma Limited, enabling its marketing in the United Stat…

• FDA approval · 2020-03-25
  FDA Approved: OMEPRAZOLE — Original Application (CHAIN DRUG MARKETING ASSOCIATION, INC.)

  The FDA approves an original application for omeprazole (generic) submitted by Chain Drug Marketing Association, Inc., covering indications …

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for esomeprazole magnesium, a generic proton pump inhibitor.

• FDA approval · 2020-03-23
  FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s Esomeprazole Magnesium as a generic version of esomeprazole under an Original Application (ANDA).

• FDA approval · 2020-03-03
  FDA Approved: LANSOPRAZOLE — Supplemental Application (Lifestar Pharma LLC.)

  FDA approves a supplemental application to allow Lifestar Pharma LLC to market a generic version of lansoprazole.

• FDA approval · 2020-02-21
  FDA Approved: CIMETIDINE 200 ACID REDUCER — Supplemental Application (Walgreen Company)

  The FDA approved a supplemental application for Walgreens' CIMETIDINE 200 ACID REDUCER, indicating approval of changes to the approved gener…

• CLINICAL_TRIALS trial_result · 2020-02-21
  Clinical Trial Update: Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis [Phase 3]

  Phase 3 trial comparing vonoprazan to lansoprazole for maintenance therapy in erosive esophagitis completed with posted results.

• FDA label_change · 2020-01-07
  FDA Approved: FAMOTIDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA notes a supplemental application for famotidine by Lupin Pharmaceuticals, likely involving labeling changes for the drug.

• FDA approval · 2020-01-03
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for pantoprazole sodium from Lannett Company (ANDA 078281).

• FDA approval · 2019-11-29
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for Rabeprazole sodium by Advagen Pharma Limited.

• FDA approval · 2019-11-15
  FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Rabeprazole sodium from Amneal Pharmaceuticals LLC (ANDA 204179).

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited.

• FDA approval · 2019-11-14
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a Supplemental Application for Pantoprazole from NorthStar RxLLC, indicating an approved revision or addition to this generic p…

• FDA approval · 2019-10-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., indicating changes or additions to the approved …