Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

Inhaler spraying — Updated climate agreements will phase down the use of hydrofluorocarbons, including in inhalers • Source: Shutterstock

Sponsors of brand respiratory drugs are expected to remove hydrofluorocarbons as the device propellant, which could leave generic companies scrambling absent help from the US Food and Drug Administration.

Janet Vaughn, Teva VP of North American generic regulatory affairs, said the FDA could use generic drug user fee...