Gastric Ulcer

• FDA approval · 2013-04-05
  FDA Approved: BASIC CARE LANSOPRAZOLE — Supplemental Application (Amazon.com Services LLC)

  FDA approved a supplemental application for BASIC CARE LANSOPRAZOLE (lansoprazole) from Amazon.com Services LLC, a generic lansoprazole prod…

• FDA approval · 2013-04-01
  FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) by Kenvue Brands LLC.

• CLINICAL_TRIALS trial_result · 2013-04-01
  Clinical Trial Update: Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer [Phase 4]

  Phase 4 clinical trial update evaluating the efficacy and safety of teprenone in patients with acute gastritis, acute gastric lesions on chr…

• FDA approval · 2013-03-04
  FDA Approved: SUCRALFATE — Supplemental Application (Mylan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SUCRALFATE submitted by Mylan Pharmaceuticals, Inc.

• FDA approval · 2013-03-04
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for Carafate (sucralfate). This action updates the labeling and approved uses based on …

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• FDA approval · 2013-02-22
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine submitted by Alembic Pharmaceuticals Inc.

• FDA approval · 2013-02-11
  FDA Approved: NIZATIDINE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma, LLC's supplemental application to market a generic nizatidine product (an H2 receptor blocker) under an ANDA, expa…

• CLINICAL_TRIALS trial_result · 2013-02-04
  Clinical Trial Update: Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation [Phase 3]

  Phase 3 trial evaluating the effectiveness and safety of Mucosta (rebamipide) for gastric ulcers has completed.

• FDA approval · 2013-01-23
  FDA Approved: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for the fixed-dose combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydr…

• FDA label_change · 2012-12-20
  FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (lansoprazole) filed by Takeda, extending its labeling with additional indications.

• FDA approval · 2012-12-19
  FDA Approved: FAMOTIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for famotidine from Teva Pharmaceuticals USA, Inc., signaling an approved modification to the produc…

• FDA approval · 2012-12-17
  FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approves Lupin Pharmaceuticals' famotidine as a generic product under an original ANDA, authorizing its marketing for approved indicatio…

• FDA approval · 2012-12-12
  FDA Approved: FAMOTIDINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for famotidine filed by Chartwell RX, LLC.

• CLINICAL_TRIALS trial_result · 2012-11-22
  Clinical Trial Update: Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin [Phase 3]

  Phase 3 trial comparing D961H to placebo for the prevention of gastric and duodenal ulcers in users of low-dose aspirin; results have been p…

• FDA approval · 2012-11-13
  FDA Approved: CIMETIDINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for cimetidine, resulting in an expanded label/approval for the drug.

• FDA approval · 2012-11-09
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for the fixed-dose combination of omeprazole and sodium bicarbonate, with u…

• FDA approval · 2012-11-02
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for omeprazole submitted by Lannett Company, Inc. The approval pertains to a change to the marketed …

• FDA approval · 2012-10-09
  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 modify/expand its labeling.

• FDA approval · 2012-10-09
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) by Covis Pharma US, Inc, indicating an approved update to the la…

• FDA approval · 2012-10-05
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC.

• FDA approval · 2012-09-28
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2012-09-28
  FDA Approved: PREVACID SOLUTAB — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Prevacid Solutab (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc.

• CLINICAL_TRIALS trial_result · 2012-09-14
  Clinical Trial Update: Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer [Phase 3]

  Phase 3 long-term study assessing the efficacy and safety of D961H esomeprazole for preventing NSAID-induced ulcers; the trial has completed…

• FDA approval · 2012-09-10
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  FDA approved a supplemental application for GOOD NEIGHBOR PHARMACY OMEPRAZOLE (omeprazole) under NDA 022032, with Amerisource Bergen as the …

• FDA approval · 2012-08-27
  FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)

  FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals under ANDA078878, approving the changes describ…