• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to secondary sidebar

OINDPnews


Proveris Scientific
  • Home
  • News
    • Business
    • Features
    • Medical
    • Regulatory
    • Products and Services
    • People
  • Events
  • Suppliers
    • Supplier listing and advertising options
    • Capsules and blisters
    • Consultants
    • Contract research
    • Contract manufacturing
    • Devices
    • Education
    • Excipients
      • Clinical Technology
    • Filling equipment
    • Instruments
    • Particle manufacturing
    • Software and modeling
  • Jobs
  • Resources
    • Webinars
    • White papers
  • LGWP Propellants
    • HFA 152a
    • HFO-1234ze(E)
    • LGWP Regulation
  • Contact

FDA advisory committee votes against approval of Linhaliq

Aradigm Corporation said that the FDA’s Antimicrobial Drugs Advisory Committee (ADAC) has voted against approval of the company’s NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients.

The company submitted the NDA in July 2017, and the FDA granted the application priority review, with a PDUFA date of January 26, 2018.

In response to the question: “Has the applicant provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa?” the committee voted 12 “no” and 3 “yes”, with 1 committee member abstaining.

Aradigm President and CEO Igor Gonda said, “While we are disappointed with the outcome of the ADAC vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in NCFBE patients. We will work closely with the FDA to address the issues discussed by the panel today as they complete their review of Linhaliq. We are committed to helping NCFBE patients, who presently have no available treatment options.”

Read the Aradigm press release.

Share

published on January 11, 2018

Primary Sidebar

Sign up for our free weekly newsletter

Upcoming Events
Sponsored by Intertek

Want information about upcoming OINDP-related events delivered directly to your inbox? click here

  • June 17-June 18: Rescon Europe 2025, Paris, France
  • June 19-June 20: Metered Dose Inhaler (MDI) Technology Training Course, online
  • June 22-June 25: ISAM Congress 2025, Washington, DC, USA
  • June 25-June 25: SMI.London 2025, London, UK
  • September 18-September 19: IPAC-RS Nasal Innovation Forum, West Trenton, NJ, USA
  • See all upcoming events

    Secondary Sidebar

    Suppliers

    Capsules and blisters
    Consultants
    Contract research
    Contract manufacturing
    Devices
    Education
    Excipients
    Filling equipment
    Instruments
    Particle manufacturing
    Software and modeling
    Catalent banner
    © 2025 OINDPnews