• 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 accepts NDA for Teva HFA “dry” nasal spray

The US FDA has accepted the new drug application (NDA) filed by Teva on May 24, 2011 for its beclomethasone dipropionate (BDP) hydrofluoroalkane nasal spray for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The BDP Nasal HFA spray uses the same formulation as Teva’s Qvar inhalation aerosol, an inhaled corticosteroid (ICS) already on the market, and would be the first “dry” or non-aqueous nasal spray on the market if approved.

Teva Group VP, Global Branded Products Yitzhak Peterburg said, “BDP Nasal HFA has demonstrated promising results in the treatment of both SAR and PAR, and we remain committed to addressing unmet needs and dissatisfaction with currently available treatments among the 60 million patients in the US who suffer from allergic rhinitis.”

According to the company, two Phase 3 trials have demonstrated that the BDP Nasal HFA significantly reduces nasal symptoms in patients with SAR and PAR compared to placebo and is well tolerated. Teva expects that patients will prefer a dry nasal spray to an aqueous spray that may drip down the backs of their throats.

Read the Teva press release.

Share

published on August 8, 2011

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
    Solstice Air banner
    © 2025 OINDPnews