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The document specifies administrative application details, dosing regimen of 1.7 mg one tablet two or three times daily, and the proposed indication as peptic ulcer. It also summarizes FDA regulatory action (approval), approved use limitations (adjunct only, not monotherapy), and outlines review areas including benefit-risk assessment, interdisciplinary evaluation, patient experience data, pharmacologic activity and clinical pharmacology, effectiveness assessment, and risk management with safety considerations.",{"@graph":69,"@context":121},[70,84,104],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/integrated-review-integrated-review/345541/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":98,"encodingFormat":97,"isAccessibleForFree":99,"interactionStatistic":100},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/integrated-review-integrated-review/345541.png","ImageObject",300,407,{"name":92,"@type":93},"Aria","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-22",true,{"@type":101,"interactionType":102,"userInteractionCount":4},"InteractionCounter",{"@type":103},"ViewAction",{"@type":105,"mainEntity":106},"FAQPage",[107,113,117],{"name":108,"@type":109,"acceptedAnswer":110},"What drug product and dosage form does the integrated review focus on?","Question",{"text":111,"@type":112},"The review focuses on Glycopyrrolate as the active substance, proposed as Dartisla ODT, an orally disintegrating tablet.","Answer",{"name":114,"@type":109,"acceptedAnswer":115},"What is the approved indication and how is it limited?",{"text":116,"@type":112},"DARTISLA ODT is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment. It is not indicated as monotherapy because effectiveness in peptic ulcer healing has not been established.",{"name":118,"@type":109,"acceptedAnswer":119},"What dosing regimen is described in the application?",{"text":120,"@type":112},"The document describes a dosing regimen of one tablet (1.7 mg) taken two or three times daily.","https://schema.org",{"og:url":83,"og:type":123,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":125,"canonical":83},"index,follow",{"doc_id":127,"site_id":62},345541,1790058035,{"code":4,"msg":5,"data":130},{"doc_id":127,"user_id":131,"nickname":92,"user_avatar":132,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":133,"file_id":134,"file_url":135,"file_type":136,"file_size":137,"view_count":4,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":138,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":128,"read_time":143},2336464648322,"https://ap-avatar.wpscdn.com/avatar/2200025388227c56fec?_k=1778556882303663488","CENTER FOR DRUG EVALUATION AND  \nRESEARCH  \nAPPLICATION NUMBER:  \n215019Orig1s000 INTEGRATED REVIEW  \nIntegrated Review  \nTable 1. Administrative Application Information  \n\n| Category | Application Information |\n| --- | --- |\n| Application type | NDA |\n| Application number(s) | 215019 |\n| Priority or standard | Standard |\n| Submit date(s) | 2/26/2021 |\n| Received date(s) | 2/26/2021 |\n| PDUFA goal date | 12/26/2021 |\n| Division/office | Division of Gastroenterology (DG) |\n| Review completion date | 12/15/2021 |\n| Established/proper name | Glycopyrrolate |\n| (Proposed) proprietary name | Dartisla ODT |\n| Pharmacologic class | Anticholinergic |\n| Code name | Click or tap here to enter name. |\n| Applicant | Edenbridge Pharmaceuticals |\n| Dosage form(s)/formulation(s) | Orally Disintegrating Tablet (ODT) |\n\n Dosing regimen  one tablet (1.7 mg) two or three times daily Applicant proposed  \nindication(s)/ population(s)  \n(b) (4)  \n| Proposed SNOMED indication | 13200003 Peptic ulcer (disorder) |\n| --- | --- |\n| Regulatory action | Approval |\n| Approved dosage (if applicable) | One tablet (1.7 mg) two or three times daily |\n| Approved indication(s)/ population(s) (if applicable) | DARTISLA ODT is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.\u003Cbr>Limitations of Use\u003Cbr>DARTISLA ODT is not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. |\n| Approved SNOMED term for indication (if applicable) | 13200003 Peptic ulcer (disorder) |\n\n* Indication proposed with original submission. Revised to the following by the Applicant in response to the 74-day letter: (b) (4)  \n (b) (4)  \ni  \nIntegrated Review Template, version 2.0 (04/23/2020)  \nReference ID: 4905916  \nTable of Contents  \nTable of Tables ..............................................................................................................v  \n[Table of Figures ........................................................................................................... vi](Table of Figures ........................................................................................................... vi)  \n[Glossary...............................](Glossary...............................)....................................................................................... 1  \nI. Executive Summary....................................................................................................2  \n1. Summary of Regulatory Action .............................................................................2  \n2. Benefit-Risk Assessment........................................................................................4  \n2.1. Benefit-Risk Framework .................................................................................4  \n2.2. Conclusions Regarding Benefit-Risk ..............................................................8  \nII. Interdisciplinary Assessment................................................................................... 10  \n3. Introduction .......................................................................................................... 10  \n3.1. Review Issue List........................................................................................... 11  \n3.1.1. Key Review Issues Relevant to Evaluation of Benefit ...........................11  \n3.1.1.1. Establishing a Scientific Bridge to Robinul Forte ............................11  \n3.1.1.2. Administration With Food................................................................11  \n3.1.1.3. Administration With Water ..............................................................12  \n3.1.2. Key Review Issues Relevant to Evaluation of Risk................................12  \n3.1.2.1. Local (Topical) Safety ......................................................................12  \n3.1.2.2. Safety in Geriatric Patients .............................................","cbCaipSX5R5O89z1","https://ap.wps.com/l/cbCaipSX5R5O89z1","pdf",1322640,74,"English","# Table of Tables\n## Glossary\n# Executive Summary\n## Summary of Regulatory Action\n## Benefit-Risk Assessment\n## Benefit-Risk Framework\n## Conclusions Regarding Benefit-Risk\n# Interdisciplinary Assessment\n## Introduction\n## Review Issue List\n## Key Review Issues Relevant to Evaluation of Benefit\n## Establishing a Scientific Bridge to Robinul Forte\n## Administration With Food\n## Administration With Water\n## Key Review Issues Relevant to Evaluation of Risk\n## Local (Topical) Safety\n## Safety in Geriatric Patients\n## Appropriate Patient Population for the Higher (1.7 mg) Dosage\n## Approach to the Review\n# Patient Experience Data\n# Pharmacologic Activity, Pharmacokinetics, and Clinical Pharmacology\n## Nonclinical Assessment of Potential Effectiveness\n# Assessment of Effectiveness\n## Dose and Dose Responsiveness\n## Clinical Trials Intended to Demonstrate Efficacy\n## Key Review Issues Relevant to Evaluation of Benefit\n## Establishing a Scientific Bridge to Robinul Forte\n## Administration With Food\n## Administration With Water\n# Risk and Risk Management\n## Potential Risks or Safety Concerns Based on Nonclinical Data\n## Potential Risks or Safety Concerns Based on Drug Class or Other Drug-Specific Factors\n## Potential Safety Concerns Identified Through Postmarket Experience\n## FDA Approach to the Safety Review\n## Adequacy of Clinical Safety Database","[{\"question\":\"What drug product and dosage form does the integrated review focus on?\",\"answer\":\"The review focuses on Glycopyrrolate as the active substance, proposed as Dartisla ODT, an orally disintegrating tablet.\"},{\"question\":\"What is the approved indication and how is it limited?\",\"answer\":\"DARTISLA ODT is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment. It is not indicated as monotherapy because effectiveness in peptic ulcer healing has not been established.\"},{\"question\":\"What dosing regimen is described in the application?\",\"answer\":\"The document describes a dosing regimen of one tablet (1.7 mg) taken two or three times daily.\"}]","Integrated Review - Integrated Review | PDF",186]