Erosive Esophagitis

• FDA approval · 2013-05-17
  FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Pantoprazole (ANDA077619) filed by NorthStar RxLLC.

• FDA approval · 2013-05-15
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Prilosec (omeprazole magnesium) filed by Covis Pharma US, Inc.

• FDA approval · 2013-04-19
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for ACIPHEX (rabeprazole sodium) submitted by Waylis Therapeutics LLC. The action expands or updates…

• FDA approval · 2013-04-19
  FDA Approved: OMEPRAZOLE/SODIUM BICARBONATE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's generic omeprazole/sodium bicarbonate (original application) for use as a proton pump inhibito…

• 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.

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• CLINICAL_TRIALS trial_result · 2013-02-25
  Clinical Trial Update: Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

  This completed clinical trial identifies factors that predict response to proton pump inhibitors in patients with gastroesophageal reflux di…

• 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 · 2013-02-08
  Clinical Trial Update: Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis [Phase 3]

  Phase 3 trial comparing a pantoprazole formulation to the currently marketed pantoprazole tablet in patients with gastroesophageal reflux di…

• CLINICAL_TRIALS trial_result · 2013-01-04
  Clinical Trial Update: A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis. [Phase 2]

  A Phase 2b dose-finding trial of AZD0865 with esomeprazole in gastroesophageal reflux disease with erosive esophagitis has completed.

• 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.

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

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cimetidine, updating the product under an existing approval.

• 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…

• CLINICAL_TRIALS trial_result · 2012-11-09
  Clinical Trial Update: Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis [Phase 3]

  A Phase 3 trial comparing vonoprazan (TAK-438) with lansoprazole for treating erosive esophagitis has completed, evaluating relative efficac…

• 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: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• 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: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Dexilant (lansoprazole) from Takeda Pharmaceuticals America, expanding its labeling and indicati…

• 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: 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.