• Login
    View Item 
    •   UMB Digital Archive
    • School of Pharmacy
    • Dr. Peter Doshi
    • View Item
    •   UMB Digital Archive
    • School of Pharmacy
    • Dr. Peter Doshi
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    Antibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    Publisher version
    View Source
    Access full-text PDFOpen Access
    View Source
    Check access options
    Check access options
    Author
    Kuzucan, Aida
    Powers, John H
    Doshi, Peter
    Journal
    Mayo Clinic Proceedings
    Publisher
    Elsevier Ltd.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1016/j.mayocp.2020.07.023
    Abstract
    Approval by the US Food and Drug Administration (FDA) of a drug for a given indication is thought to reassure clinicians, other health care providers, and patients that substantial evidence of effectiveness exists for specific indicated populations (patients and diseases). This study examines whether FDA approval of certain antibiotics should be so reassuring for all patient populations identified in the FDA-approved labels. Specifically, this study compared patient populations covered by FDA-approved labels for 21 novel antibiotics approved between 1999 and 2018 to the patient exclusion and inclusion criteria of pivotal trials that supported those approvals. We found that every FDA-approved label for these antibiotics included at least one identifiable patient population that was explicitly excluded from enrolling in the supporting pivotal trials. Two antibiotics, bedaquiline and ceftazidime-avibactam, were approved for use in populations that were fully excluded from enrolling in registration trials.
    Rights/Terms
    Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
    Keyword
    FDA
    patient populations
    United States. Food and Drug Administration
    Anti-Bacterial Agents
    Clinical Trials as Topic
    Drug Approval
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/14208
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.mayocp.2020.07.023
    Scopus Count
    Collections
    Dr. Peter Doshi

    entitlement

    Related articles

    • Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.
    • Authors: Deak D, Outterson K, Powers JH, Kesselheim AS
    • Issue date: 2016 Sep 6
    • Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
    • Authors: Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD
    • Issue date: 2019 May 3
    • Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials.
    • Authors: Shepshelovich D, Tibau A, Goldvaser H, Molto C, Ocana A, Seruga B, Amir E
    • Issue date: 2018 Jun 20
    • Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials.
    • Authors: Shepshelovich D, Tibau A, Goldvaser H, Ocana A, Seruga B, Amir E
    • Issue date: 2019 Jan
    • Assessment of Data Supporting the Efficacy of New Antibiotics for Treating Infections Caused by Multidrug-resistant Bacteria.
    • Authors: Yahav D, Tau N, Shepshelovich D
    • Issue date: 2021 Jun 1
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.