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Metered Dose Inhaler Propellant Transition: US FDA Eager To Avoid Replay Of CFC-To-HFA ‘Complexity’

 
• By Michael McCaughan

The US FDA wants a smoother transition to newer “low global warming potential” propellants in metered dose inhalers than the prior transition away from CFCs.

The FDA wants the transition to "low global warming potential" metered dose inhaler propellants to have a minimal impact on patients. (Shutterstock)
Key Takeaways
  • The FDA hopes the transition away from HFA propellants in metered dose inhalers is not as complicated as the transition from CFC to HFA propellants.
  • Sponsors are not expected to reformulate their products, but supply chain and cost problems are expected.
  • During a recent workshop, the FDA outlined a development framework that eventually could become a guidance document.

The US Food and Drug Administration is planning to transition away from the hydrofluoroalkane (HFA) propellants currently used in metered dose inhalers and is eager to avoid many of the...

“The CFC to HFA transition was a very complex, multi-year process … that was very complicated and burdensome for us, and as well as for industry,” Sally Seymour, director of...

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