FDA Perspectives on Scientific and Regulatory Considerations for MDIs Transitioning to a Low Global Warming Potential Propellant
Newman B, Luke M.
Respiratory Drug Delivery 2024. Volume 1, 2024: 154-160.
Abstract:
The current transition for metered dose inhalers (MDIs) from currently used hydrofluoroalkane (HFA)-based propellants to low global warming potential (LGWP) propellants is a complex and challenging endeavor for MDI developers, health and regulatory agencies, and the patients prescribed these treatments. This article provides the US Food and Drug Administration (FDA) current perspective on this transition, including how FDA’s experience with the chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) propellant transition, along with the current scientific understanding of LGWP propellants, informs the Agency’s current thinking regarding brand-name and generic LGWP propellant MDI development programs.
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