Erosive Esophagitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2014-05-19Clinical Trial Update: TAK-438 - Safety, Blood Levels & Effects of Repeated Doses [Phase 1]
A Phase 1 study evaluating the safety, pharmacokinetics (blood levels), and effects of repeated doses of TAK-438 (vonoprazan) in participant…
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FDA approval · 2014-02-25FDA Approved: PRILOSEC — Supplemental Application (Covis Pharma US, Inc)
FDA approved a supplemental application for Prilosec (omeprazole magnesium) from Covis Pharma US, Inc. The approval updates the labeling for…
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FDA label_change · 2014-02-25FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca, resulting in changes to the product la…
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FDA approval · 2014-02-14FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
FDA approved a supplemental application for Omeprazole Magnesium by Gericare Pharmaceuticals, updating the approval status for this generic …
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CLINICAL_TRIALS trial_result · 2014-02-10Clinical Trial Update: A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis [Phase 3]
A Phase 3 randomized, double-blind study evaluating TAK-438 (vonoprazan) at 20 mg and 40 mg for patients with proton pump inhibitor-resistan…
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FDA approval · 2013-12-20FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved a supplemental application for the combination product Omeprazole and Sodium Bicarbonate from Oceanside Pharmaceuticals.
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FDA approval · 2013-12-19FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for omeprazole from Sandoz Inc, authorizing updates to the approved generic product.
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FDA approval · 2013-12-12FDA Approved: PROTONIX I.V. — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PROTONIX I.V. (pantoprazole sodium), adding an intravenous formulation to treat gastroesophageal…
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FDA label_change · 2013-12-10FDA 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) to update the product labeling. The sponsor is Wy…
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FDA approval · 2013-12-10FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for pantoprazole sodium (generic) submitted by Lannett Company, Inc., indicating an additional regul…
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FDA approval · 2013-11-08FDA Approved: RABEPRAZOLE SODIUM — Original Application (Lannett Company, Inc.)
FDA approved the original application for rabeprazole sodium from Lannett Company, Inc., enabling a generic version of the proton pump inhib…
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FDA approval · 2013-11-08FDA Approved: RABEPRAZOLE SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approves Torrent Pharmaceuticals Limited's original application for generic rabeprazole sodium, a proton pump inhibitor indicated for ga…
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CLINICAL_TRIALS trial_result · 2013-11-05Clinical Trial Update: Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis [Phase 3]
A Phase 3 long-term safety study of TAK-438 (vonoprazan) for maintaining healing in erosive esophagitis has completed, reporting safety data…
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FDA approval · 2013-10-31FDA Approved: OMEPRAZOLE MAGNESIUM — Supplemental Application (Gericare Pharmaceuticals)
The FDA approved a supplemental application for omeprazole magnesium from Gericare Pharmaceuticals, granting approval for a generic product …
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FDA approval · 2013-10-04FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP.
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FDA label_change · 2013-09-13FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
The FDA lists a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen, typically related to lab…
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FDA approval · 2013-08-27FDA Approved: LANSOPRAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Lansoprazole from Mylan Pharmaceuticals Inc., resulting in approval of a generic Lansoprazol…
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CLINICAL_TRIALS trial_result · 2013-08-23Clinical Trial Update: Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis [Phase 3]
Phase 3 trial comparing TAK-438 (vonoprazan) to lansoprazole for maintenance therapy in healed erosive esophagitis; the update reports effic…
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FDA approval · 2013-08-20FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) submitted by Takeda Pharmaceuticals America, Inc., resulting in updat…
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FDA approval · 2013-08-16FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy's omeprazole, enabling changes to the previously approved labeling for th…
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FDA approval · 2013-08-07FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc. under ANDA090970, allowing continued marketi…
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FDA approval · 2013-08-06FDA Approved: ESOMEPRAZOLE STRONTIUM — Original Application (R2 Pharma, LLC)
FDA approved esomeprazole strontium via the Original Application (NDA202342) for indications consistent with proton pump inhibitors (GERD-re…
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FDA approval · 2013-06-30FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Omeprazole from Apotex Corp, confirming approval of a supplemental filing for this generic proto…
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FDA approval · 2013-06-13FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for pantoprazole sodium from NorthStar Rx LLC, indicating an approved change to an existing pant…
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FDA approval · 2013-05-30FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for pantoprazole sodium submitted by Torrent Pharmaceuticals Limited (generic pantoprazole) under an…