Erosive Esophagitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-12-16FDA Approved: PREVACID — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PREVACID (lansoprazole) submitted by Takeda Pharmaceuticals America, Inc. The approval updates t…
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FDA label_change · 2015-12-16FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA supplemental application submission for Dexilant (dexlansoprazole) by Takeda Pharmaceuticals America, Inc., potentially seeking an updat…
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FDA approval · 2015-11-09FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application to add an intravenous formulation of pantoprazole (PROTONIX I.V.) from Wyeth/Pfizer, enabling IV…
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FDA approval · 2015-09-25FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (NorthStar Rx LLC)
FDA approved the original application for esomeprazole magnesium from NorthStar Rx LLC, a generic version of the proton pump inhibitor esome…
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FDA approval · 2015-08-19FDA Approved: OMEPRAZOLE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic omeprazole product.
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FDA approval · 2015-08-03FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for Esomeprazole Magnesium from Mylan as a generic proton pump inhibitor. The approval makes a generic …
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FDA approval · 2015-07-31FDA Approved: RABEPRAZOLE SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the Original Application for a generic rabeprazole sodium product by Amneal Pharmaceuticals. The approval supporting use for ac…
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CLINICAL_TRIALS trial_result · 2015-06-23Clinical Trial Update: Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD) [Phase 3]
Phase 3 head-to-head trial comparing Rabeprazole Extended-Release 50 mg with Esomeprazole 40 mg for healing and symptomatic relief in modera…
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FDA approval · 2015-06-01FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, allowing the …
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents [Phase 2]
Phase 2 study in adolescents evaluating the safety and efficacy of dexlansoprazole delayed-release capsules for healing erosive esophagitis,…
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FDA approval · 2015-04-20FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)
FDA approved a supplemental application for Pepcid AC Maximum Strength (famotidine) filed by Kenvue Brands LLC to update the OTC product lab…
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FDA approval · 2015-04-14FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved Sandoz Inc's supplemental application for omeprazole, a generic proton pump inhibitor.
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FDA approval · 2015-04-09FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited under the ANDA program. This action upd…
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FDA approval · 2015-04-08FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approves a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc. under ANDA.
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FDA approval · 2015-04-08FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
FDA approves a supplemental application for pantoprazole from NorthStar RxLLC, indicating approval of a generic pantoprazole product.
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FDA approval · 2015-04-08FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Pantoprazole Sodium from NorthStar Rx LLC under an ANDA (202038), authorizing regulatory action …
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FDA approval · 2015-04-03FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett's generic rabeprazole sodium (ANDA 090678), authorizing its marketing as a proton pump i…
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FDA approval · 2015-04-02FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for rabeprazole sodium from Torrent Pharmaceuticals Limited under ANDA 202376, indicating a post…
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FDA approval · 2015-03-20FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for omeprazole from Apotex Corp., authorizing a generic version of the drug.
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FDA approval · 2015-03-16FDA Approved: OMEPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for omeprazole submitted by Dr. Reddy's Laboratories Limited.
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FDA label_change · 2015-03-16FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for lansoprazole submitted by Mylan Pharmaceuticals, indicating a change to the product labeling/aut…
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FDA approval · 2015-03-06FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) submitted by AmerisourceBergen, under NDA 022032.
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CLINICAL_TRIALS trial_result · 2015-03-06Clinical Trial Update: Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets [Phase 1]
Phase 1 sensory evaluation study of dexlansoprazole delayed-release orally disintegrating tablets completed, with results posted in 2015 reg…
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FDA approval · 2015-03-02FDA Approved: OMEPRAZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for omeprazole from Zydus Lifesciences Limited under the ANDA.
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FDA approval · 2015-02-25FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA has approved a supplemental application for Pantoprazole Sodium from Torrent Pharmaceuticals Limited, resulting in the approval of the g…