We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Approves Xenleta for Community-Acquired Bacteria Pneumonia

FDA Approves Xenleta for Community-Acquired Bacteria Pneumonia

Purple_Approved_Stamp.gif
August 22, 2019

Nabriva Therapeutics won FDA approval for Xenleta (lefamulin) to treat community-acquired bacterial pneumonia (CBAP).

Available as an oral tablet and an intravenous  formula, the antibiotic is used to treat adult patients with CBAP, a pneumonia infection acquired outside of hospital and healthcare settings.

The drug’s approval was based on the results of two clinical trials which compared treatment with Xenleta to treatment with moxifloxacin in a total of 1,289 patients. The results showed that patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

  • FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

  • FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers

  • FDA Issues EUA for Monkeypox Vaccine

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing