Gastroesophageal Reflux Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-02-28FDA Approved: OMEPRAZOLE — Supplemental Application (Apotex Corp)
The FDA approved a supplemental application for omeprazole from Apotex Corp, supporting a new generic entry for the product.
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FDA approval · 2022-02-18FDA Approved: PEPCID AC MAXIMUM STRENGTH — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental application for PEPCID AC MAXIMUM STRENGTH (famotidine) from Kenvue Brands LLC.
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CLINICAL_TRIALS trial_result · 2022-02-18Clinical Trial Update: Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD [NA]
Clinical trial assessing the effects of human refluxate on macrophage phenotype in relation to GERD; completed with posted results.
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FDA approval · 2022-01-28FDA Approved: CURIST ACID RELIEF — Original Application (Little Pharma, Inc.)
The FDA approved CURIST ACID RELIEF, a 20 mg famotidine tablet from Little Pharma, Inc., under an original ANDA.
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EMA withdrawal · 2022-01-18EMA Withdrawn: Pantoloc Control (pantoprazole) — Takeda GmbH
Pantoloc Control (pantoprazole) has been withdrawn from the European market by Takeda GmbH.
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FDA approval · 2022-01-07FDA Approved: FAMOTIDINE — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' original application for famotidine, establishing a new generic entry for the acid-reducing medication…
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CLINICAL_TRIALS trial_result · 2021-12-03Clinical Trial Update: Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study [NA]
A randomized, sham-controlled trial (RESPECT) evaluating EsophyX TIF for gastroesophageal reflux disease and hiatal hernia has completed and…
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CLINICAL_TRIALS trial_result · 2021-12-03Clinical Trial Update: Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study [Phase 1]
Pilot Phase 1 study examining pantoprazole pharmacokinetics and CYP2C19 activity in children and adolescents with GERD.
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FDA approval · 2021-11-14FDA Approved: LANSOPRAZOLE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lansoprazole from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2021-11-12FDA Approved: LANSOPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals' lansoprazole, a generic proton pump inhibitor, under ANDA 203083.
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FDA approval · 2021-11-09FDA Approved: LANSOPRAZOLE — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s supplemental application for lansoprazole (generic). This action approves a generic Lansoprazole produ…
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FDA approval · 2021-11-03FDA Approved: FAMOTIDINE — Original Application (Ascent Pharmaceuticals, Inc.)
The FDA approves the original generic application for famotidine by Ascent Pharmaceuticals, Inc., enabling a generic version of this H2 bloc…
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FDA approval · 2021-10-21FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Omeprazole (omeprazole) manufactured by AmerisourceBergen.
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FDA approval · 2021-10-15FDA Approved: LANSOPRAZOLE — Supplemental Application (Dr.Reddy's Laboratories Ltd.)
The FDA approved a supplemental application for lansoprazole by Dr. Reddy's Laboratories Ltd. This approval updates the current marketing au…
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FDA approval · 2021-10-15FDA Approved: FAMOTIDINE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved an original application for famotidine from XLCare Pharmaceuticals, Inc., marking the approval of a generic famotidine product.
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CLINICAL_TRIALS withdrawal · 2021-10-08Clinical Trial Update: Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications [Phase 4]
A Phase 4 trial investigating pantoprazole's effects on levels of prescribed psychiatric medications has been withdrawn.
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CLINICAL_TRIALS research · 2021-09-20Clinical Trial Update: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease [NA]
A completed clinical trial focused on precision approaches to PPI therapy for gastroesophageal reflux disease and laryngopharyngeal reflux; …
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FDA approval · 2021-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for rabeprazole sodium (generic) from Ascend Laboratories, LLC.
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FDA approval · 2021-08-30FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic rabeprazole sodium product from Aurobindo Pharma Limited.
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FDA approval · 2021-08-25FDA Approved: NEXIUM — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Nexium (esomeprazole magnesium) submitted by AstraZeneca Pharmaceuticals LP. The approval up…
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CLINICAL_TRIALS trial_result · 2021-08-18Clinical Trial Update: A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs) [Phase 3]
Phase 3 trial of IW-3718 for 8 weeks in GERD patients on PPIs was terminated; results posted in 2021.
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CLINICAL_TRIALS trial_result · 2021-08-18Clinical Trial Update: Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs) [Phase 3]
Phase 3 trial of IW-3718 in GERD patients on PPIs completed; results posted in 2021.
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CLINICAL_TRIALS trial_result · 2021-08-03Clinical Trial Update: Spirulina Platensis for PPI Withdrawal [Phase 2]
Phase 2 clinical trial evaluating spirulina platensis for withdrawal from proton pump inhibitors in gastroesophageal reflux disease and dysp…
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FDA approval · 2021-07-26FDA Tentative Approval: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)
The FDA issued tentative approval for Civica, Inc.'s pantoprazole sodium supplemental application (NDA 209463), enabling tentative U.S. mark…
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FDA approval · 2021-07-20FDA Approved: FAMOTIDINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for famotidine from Dr. Reddy's Laboratories Limited.