Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for omeprazole (generic), granting changes to the approved ANDA product labeling.
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FDA approval · 2023-07-18FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for pantoprazole sodium by Civica, Inc., likely involving labeling or indication changes.
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE AND SODIUM BICARBONATE — Supplemental Application (Oceanside Pharmaceuticals)
The FDA approved Oceanside Pharmaceuticals' supplemental application for omeprazole and sodium bicarbonate, updating the product labeling ac…
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FDA label_change · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for omeprazole, resulting in updated labeling for the product. This is a s…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for omeprazole by Aurobindo Pharma Limited. The action provides regulatory clearance for the generic…
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FDA approval · 2023-07-18FDA Approved: OMEPRAZOLE — Supplemental Application (Golden State Medical Supply, Inc.)
FDA approved a supplemental application for the generic drug omeprazole from Golden State Medical Supply, Inc.
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FDA approval · 2023-07-12FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Aurohealth LLC)
FDA approved esomeprazole magnesium as a generic drug from Aurohealth LLC under ANDA 214473.
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FDA approval · 2023-07-07FDA Approved: FAMOTIDINE — Original Application (Biocon Pharma Inc.)
FDA approved Biocon Pharma Inc.'s original ANDA for famotidine, enabling a generic version of the H2 blocker for the treatment and preventio…
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FDA approval · 2023-06-30FDA Approved: LANSOPRAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for lansoprazole from Teva Pharmaceuticals USA, Inc., updating/expanding the approval for the generi…
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FDA approval · 2023-06-16FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Edenbridge Pharmaceuticals LLC.)
FDA approves Edenbridge Pharmaceuticals' pantoprazole sodium generic under an Original Application (ANDA).
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FDA approval · 2023-06-16FDA Approved: FAMOTIDINE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approves the original Abbreviated New Drug Application for famotidine from Upsher-Smith Laboratories, LLC, granting a generic version of…
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FDA approval · 2023-06-07FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for esomeprazole magnesium (generic) from Zydus Pharmaceuticals USA Inc. The approval covers the same …
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EMA approval · 2023-05-25EMA Authorised: Pantozol Control (pantoprazole) — Takeda GmbH
Authorisation of Pantozol Control (pantoprazole) by EMA for gastroesophageal reflux disease.
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EMA approval · 2023-05-25EMA Authorised: Controloc Control (pantoprazole) — Takeda GmbH
EMA authorised Controloc Control (pantoprazole) by Takeda GmbH for gastroesophageal reflux disease.
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EMA approval · 2023-05-24EMA Authorised: Somac Control (pantoprazole) — Takeda GmbH
Authorisation of Somac Control (pantoprazole) by Takeda GmbH for gastroesophageal reflux disease.
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved Sun Pharmaceutical Industries' supplemental application for esomeprazole magnesium (generic), a proton pump inhibitor, under th…
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FDA approval · 2023-05-22FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' supplemental application for esomeprazole magnesium delayed-release capsules (generic esomeprazole mag…
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FDA approval · 2023-05-15FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)
The FDA approved the original ANDA for famotidine from Ascend Laboratories, LLC, enabling a generic version of the H2 blocker to enter the m…
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CLINICAL_TRIALS trial_result · 2023-05-08Clinical Trial Update: Management of Reflux After Sleeve Using Stretta [NA]
Clinical trial update for management of reflux after sleeve using Stretta; study terminated with results posted.
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FDA approval · 2023-04-28FDA Approved: OMEPRAZOLE — Original Application (Aurohealth LLC)
FDA approved Aurohealth LLC's original ANDA for omeprazole, enabling the marketing of a generic proton pump inhibitor in the United States. …
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FDA approval · 2023-04-27FDA Approved: ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for Esomeprazole Magnesium, a generic proton pump inhibitor, marking a rou…
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FDA approval · 2023-04-24FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
FDA approved a supplemental application for ZEGERID OTC (omeprazole and sodium bicarbonate) from Riley Consumer Care LLC.
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FDA approval · 2023-04-13FDA Approved: DEXILANT — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Dexilant (dexlansoprazole) from Takeda Pharmaceuticals America, Inc., to update the labeling bas…
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FDA approval · 2023-04-06FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for pantoprazole sodium from Mylan Pharmaceuticals Inc., granting approval of a generic pantopra…
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FDA approval · 2023-03-30FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Advagen Pharma Limited)
FDA approved a supplemental application for rabeprazole sodium filed by Advagen Pharma Limited, indicating an approved amendment to an exist…