Duodenal Ulcer

• FDA approval · 2011-01-20
  FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)

  FDA approved Lannett Company's original Abbreviated New Drug Application for pantoprazole sodium, enabling a generic pantoprazole product. T…

• FDA approval · 2011-01-19
  FDA Approved: PANTOPRAZOLE — Original Application (NorthStar RxLLC)

  FDA approved the original application for pantoprazole submitted by NorthStar RxLLC, launching a generic pantoprazole product.

• FDA approval · 2011-01-07
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for omeprazole from Sandoz Inc., granting an additional approval under the ANDA for the generic …

• FDA approval · 2011-01-06
  FDA Approved: FAMOTIDINE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for famotidine submitted by Baxter Healthcare Corporation, resulting in a label change for the produ…

• FDA approval · 2010-12-21
  FDA Approved: CARAFATE — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Carafate (sucralfate) submitted by Allergan, Inc.

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• FDA approval · 2010-11-23
  FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Omeprazole from Sandoz Inc, granting approval for this generic proton pump inhibitor under an AN…

• FDA approval · 2010-11-17
  FDA Approved: OMEPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for the generic omeprazole from Lannett Company, Inc., authorizing continued marketing under the…

• FDA approval · 2010-10-29
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited, authorizing a modification to an existing …

• FDA approval · 2010-10-27
  FDA Approved: RANITIDINE — Supplemental Application (Pharmaceutical Associates, Inc.)

  The FDA approved a supplemental application for ranitidine submitted by Pharmaceutical Associates, Inc. The approval updates the product's e…

• FDA approval · 2010-09-03
  FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) from Wyeth Pharmaceuticals LLC (a Pfizer subs…

• FDA approval · 2010-09-03
  FDA Approved: ACIPHEX — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2010-09-03
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental application for Omeprazole and Sodium Bicarbonate.

• FDA approval · 2010-09-03
  FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Prilosec (omeprazole magnesium) submitted by Covis Pharma US, Inc., representing a labeling amen…

• FDA label_change · 2010-07-16
  FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)

  The FDA approved a labeling supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen. The update m…

• FDA approval · 2010-07-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for famotidine from Alembic Pharmaceuticals Inc., adding approved changes to the product under the A…

• FDA approval · 2010-07-15
  FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2010-06-29
  FDA Approved: FAMOTIDINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for famotidine, a generic H2 blocker used for ulcers and GERD indications.

• CLINICAL_TRIALS trial_result · 2010-06-08
  Clinical Trial Update: Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets [NA]

  An ongoing clinical trial update comparing ulcer healing in patients taking rabeprazole with different antiplatelets. The study covers gastr…

• CLINICAL_TRIALS trial_result · 2010-05-28
  Clinical Trial Update: Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID [Phase 3]

  Phase 3 trial comparing esomeprazole with placebo for prevention of NSAID-associated gastric and duodenal ulcers; results completed and post…

• FDA approval · 2010-05-27
  FDA Approved: FAMOTIDINE — Original Application (Navinta LLC)

  FDA approves Navinta LLC's original application for famotidine. This approval permits a generic version of famotidine to enter the market.

• FDA approval · 2010-04-30
  FDA Approved: RANITIDINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for ranitidine from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2010-03-04
  FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2010-01-20
  FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application to update the labeling for Omeprazole and Sodium Bicarbonate (Oceanside Pharmaceuticals).

• FDA approval · 2009-11-18
  FDA Approved: NIZATIDINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's nizatidine original application (generic) for use in conditions treated by H2 blockers.

• FDA approval · 2009-11-10
  FDA Approved: LANSOPRAZOLE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved an original ANDA for lansoprazole from Teva Pharmaceuticals USA, Inc., allowing a generic version of the proton pump inhibitor.…