Gallstone Disease
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-12-06FDA Approved: URSODIOL — Supplemental Application (Laurus Labs Limited)
FDA approved Laurus Labs Limited's supplemental application for ursodiol (ursodeoxycholic acid) under an ANDA.
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FDA approval · 2023-11-28FDA Approved: URSODIOL — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for URSODIOL by Zydus Pharmaceuticals (USA) Inc.
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FDA approval · 2023-10-26FDA Approved: URSODIOL — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for ursodiol (ursodeoxycholic acid) from Lannett Company, Inc., adding changes to the existing appro…
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FDA approval · 2023-10-25FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Ursodiol from Strides Pharma Science Limited, expanding or updating its labeling/indications…
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FDA approval · 2023-10-25FDA Approved: URSODIOL — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for URSODIOL from Aurobindo Pharma Limited, resulting in approval of the generic ursodiol product un…
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FDA approval · 2023-07-19FDA Approved: URSODIOL — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for URSODIOL from Actavis Pharma, Inc.
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FDA approval · 2023-06-30FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Ursodiol (ursodiol) from Strides Pharma Science Limited.
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FDA approval · 2023-04-25FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for URSODIOL from BluePoint Laboratories.
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FDA approval · 2023-01-12FDA Approved: URSO 250 — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for URSO 250 (ursodiol) submitted by Allergan, Inc.
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FDA approval · 2021-11-29FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Ursodiol (URSODIOL) submitted by BluePoint Laboratories.
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FDA approval · 2020-08-17FDA Approved: URSODIOL — Original Application (Chartwell RX, LLC)
FDA approved URSODIOL (ursodiol) from Chartwell RX, LLC under an Original Application (ANDA).
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FDA approval · 2020-02-12FDA Approved: URSODIOL — Original Application (Laurus Labs Limited)
FDA approves Laurus Labs Limited's URSODIOL under an Original Application (ANDA) for a generic ursodiol product.
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CLINICAL_TRIALS trial_result · 2019-02-19Clinical Trial Update: Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP
A completed prospective study evaluated residual bile duct stones after conventional ERCP using peroral cholangioscopy to detect remaining s…
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CLINICAL_TRIALS trial_result · 2018-11-30Clinical Trial Update: Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy [Phase 4]
Phase 4 trial comparing intraoperative lidocaine infusion to esmolol infusion for postoperative analgesia after laparoscopic cholecystectomy…
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FDA approval · 2018-10-16FDA Approved: URSODIOL — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal's Ursodiol generic under an Original Application (ANDA 211301), enabling its marketing as a generic therapy.
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CLINICAL_TRIALS trial_result · 2018-07-05Clinical Trial Update: RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones [NA]
An RCT evaluating whether cholecystectomy is necessary after clearance of bile duct stones; the study is completed.
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CLINICAL_TRIALS trial_result · 2016-10-18Clinical Trial Update: Obeticholic Acid in Bariatric and Gallstone Disease [Phase 2]
This clinical trial update notes that a Phase 2 study of obeticholic acid for obesity-related bariatric and gallstone disease has completed.
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CLINICAL_TRIALS trial_result · 2016-06-30Clinical Trial Update: Comparison of Coagulation Factors During Laparoscopic Cholecystectomy [NA]
A clinical trial comparing coagulation factors during laparoscopic cholecystectomy in patients with gallstone disease and gallbladder polyps…
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FDA approval · 2016-06-27FDA Approved: URSODIOL — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for Ursodiol by Actavis Pharma, Inc., updating its labeling and indications. The action likely e…
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CLINICAL_TRIALS research · 2016-06-21Clinical Trial Update: The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute
This update describes a single-institution, age- and sex-matched case-control study on risk factors for symptomatic gallstones, with the stu…
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CLINICAL_TRIALS trial_result · 2016-03-08Clinical Trial Update: The Discovery of the Double Sphincter in Gallbladder [Phase 4]
Phase 4 clinical trial update related to gallstone disease, noting a reported discovery of a double sphincter in the gallbladder and with th…
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CLINICAL_TRIALS trial_result · 2015-11-20Clinical Trial Update: The Impact of Physical Activity on the Outcome of Surgery
A completed clinical trial from Sahlgrenska University Hospital examines how physical activity influences postoperative outcomes in patients…
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CLINICAL_TRIALS research · 2015-07-29Clinical Trial Update: P6 Acupressure Before Laparoscopic Cholecystectomy [NA]
A clinical trial update from Saglik Bilimleri Universitesi Gulhane Tip Fakultesi evaluating acupressure before laparoscopic cholecystectomy …
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CLINICAL_TRIALS trial_result · 2015-07-23Clinical Trial Update: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy [NA]
The study evaluated combined spinal-epidural and general anesthesia for laparoscopic cholecystectomy, with completion and results posted in …
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CLINICAL_TRIALS trial_result · 2015-06-12Clinical Trial Update: Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
A completed validation study evaluating the accuracy of surgeon-performed ultrasound in detecting gallstones, assessing its potential as a d…