• 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

Padagis announces submission of ANDA for generic of Kloxxado naloxone nasal spray

Padagis announced two recent ANDA submissions, including an ANDA for a generic version of Hikma’s Kloxxado naloxone nasal spray for the reversal of opioid overdose. Kloxxado, which delivers an 8 mg dose of naloxone compared to a 4 mg dose for Narcan nasal spray, was approved by the FDA in April 2021. Padagis launched a generic version of Narcan in the US in June 2022.

According to Padagis, Hikma filed a patent infringement suit in the US District Court for the District of Delaware on June 14, 2023 after receiving notification of the ANDA submission.

Padagis President Pam Hoffman commented, “The investments in our pipeline made by Padagis since our inception have begun to bear fruit. Two first-to-file ANDA submissions speak to the innovation and execution capabilities of the Padagis team. Most importantly, these achievements are the embodiment of our mission to bring high-quality, affordable products to our customers and patients.”

Read the Padagis press release.

Share

published on June 19, 2023

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
    Bespak Leading the Green Transition banner
    © 2025 OINDPnews