Gastroesophageal Reflux Disease
📧 Sign up to get email alerts when something new happens for Gastroesophageal Reflux Disease.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2023-03-28Clinical Trial Update: Physiology of GERD and Treatment Response [NA]
A completed clinical trial investigating the physiology of gastroesophageal reflux disease (GERD) and treatment response, with results poste…
-
FDA approval · 2023-03-28FDA Approved: ESOMEPRAZOLE MAGNESIUM — Original Application (Solco Healthcare US LLC)
FDA approves esomeprazole magnesium under an Original Application for Solco Healthcare US LLC, enabling a generic version of the proton pump…
-
FDA approval · 2023-03-08FDA Approved: ESOMEPRAZOLE SODIUM — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for esomeprazole sodium from Gland Pharma Limited, expanding the generic's regulatory approval. The …
-
FDA approval · 2023-03-08FDA Approved: ORIGINAL STRENGTH HEARTBURN PREVENTION — Original Application (KROGER COMPANY)
FDA approved Kroger's Original Strength Heartburn Prevention as an ANDA for famotidine, including 10 mg and 20 mg strengths.
-
FDA approval · 2023-02-09FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Ajanta Pharma USA Inc.)
FDA approved Pantoprazole Sodium as an original generic product (ANDA 217416) for Ajanta Pharma USA Inc., expanding access to pantoprazole s…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS withdrawal · 2023-01-05Clinical Trial Update: Cardiac Safety of Lansoprazole and Domperidon Combination [Phase 4]
A Phase 4 trial evaluating the cardiac safety of a lansoprazole and domperidone combination was withdrawn.
-
FDA approval · 2022-12-13FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
FDA approved a supplemental application for ZEGERID OTC (omeprazole sodium bicarbonate) from Riley Consumer Care LLC.
-
CLINICAL_TRIALS trial_result · 2022-11-21Clinical Trial Update: Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS [Phase 4]
Phase 4 trial reporting efficacy and safety of Neobianacid® for GERD and EPS has been completed.
-
FDA approval · 2022-11-01FDA Approved: ZEGERID OTC — Supplemental Application (Riley Consumer Care LLC)
FDA approved a supplemental application for ZEGERID OTC by Riley Consumer Care LLC. The product contains omeprazole sodium bicarbonate.
-
FDA approval · 2022-11-01FDA Approved: EQUATE LANSOPRAZOLE — Supplemental Application (Wal-Mart Stores Inc)
FDA approved a supplemental application for Equate Lansoprazole, Wal-Mart's store-brand lansoprazole. The approval confirms the Wal-Mart Sto…
-
FDA approval · 2022-10-04FDA Approved: PRILOSEC OTC — Supplemental Application (The Procter & Gamble Manufacturing Company)
FDA approved a supplemental application for Prilosec OTC (omeprazole magnesium) from The Procter & Gamble Manufacturing Company, updating it…
-
FDA approval · 2022-09-30FDA Approved: GOOD NEIGHBOR PHARMACY OMEPRAZOLE — Supplemental Application (Amerisource Bergen)
FDA granted a supplemental approval for Good Neighbor Pharmacy Omeprazole (omeprazole) from AmerisourceBergen.
-
FDA label_change · 2022-09-27FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for pantoprazole sodium from Sun Pharmaceutical Industries, resulting in an updated labeling for the…
-
FDA approval · 2022-09-16FDA Approved: DEXLANSOPRAZOLE DELAYED RELEASE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved a generic dexlansoprazole delayed-release tablet by Upsher-Smith Laboratories, LLC under an original ANDA.
-
FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Rabeprazole sodium submitted by Aurobindo Pharma Limited.
-
FDA approval · 2022-09-14FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for rabeprazole sodium (Ascend Laboratories, LLC). This indicates regulatory approval of the generic…
-
FDA approval · 2022-09-06FDA Approved: NEXIUM 24HR CLEARMINIS — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NEXIUM 24HR CLEARMINIS (esomeprazole magnesium) from Haleon US Holdings LLC.
-
FDA approval · 2022-09-06FDA Approved: NEXIUM 24HR — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for Nexium 24HR (esomeprazole magnesium) submitted by Haleon US Holdings LLC.
-
FDA approval · 2022-09-02FDA Approved: RABEPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for rabeprazole sodium submitted by Torrent Pharmaceuticals Limited.
-
FDA approval · 2022-08-29FDA Approved: PANTOPRAZOLE SODIUM — Original Application (Northstar Rx LLC)
FDA approved Pantoprazole sodium as an original ANDA for a generic product manufactured by Northstar Rx LLC.
-
FDA approval · 2022-08-25FDA Approved: ZANTAC 360 — Supplemental Application (Chattem, Inc.)
The FDA approved a supplemental application for ZANTAC 360 (famotidine) submitted by Chattem, Inc., under ANDA206531.
-
FDA approval · 2022-08-15FDA Approved: PANTOPRAZOLE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application for pantoprazole filed by NorthStar RxLLC.
-
FDA approval · 2022-08-11FDA Approved: PANTOPRAZOLE SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for pantoprazole sodium from Torrent Pharmaceuticals Limited. The action is a supplemental approval,…
-
FDA approval · 2022-08-04FDA Approved: FAMOTIDINE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves Amneal's original application for famotidine, enabling a generic version of the H2 blocker. The approval covers common indicati…
-
FDA approval · 2022-07-28FDA Approved: FAMOTIDINE — Supplemental Application (Akorn)
FDA approved a supplemental application for famotidine from Akorn (ANDA 201995). This approval confirms continued availability of this gener…