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

OINDPnews


Intertek banner
  • 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 approves PulmoFlow’s Kitabis Pak for CF

PulmoFlow has announced that the FDA has approved its NDA for Kitabis Pak, generic tobramycin inhalation solution packaged with a PARI LC PLUS nebulizer, for the treatment P. aeruginosa infections in cystic fibrosis patients. PARI Respiratory Equipment will distribute the product, which will be priced similarly to generic tobramycin alone, the company said.

In August 2014, the FDA said that it had tentatively approved PulmoFlow’s tobramycin inhalation solution.

PARI USA President Geoff Hunziker commented, “Our goal is to streamline the process so patients receive tobramycin inhalation solution with the nebulizer proven to deliver it effectively. Kitabis Pak is the easiest and most cost effective way for doctors to prescribe nebulized tobramycin without the added hassle of a separate nebulizer prescription or cost.”

Read the PulmoFlow press release.

Share

published on December 3, 2014

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
    Proveris_180x150a
    © 2025 OINDPnews