FDA approves non-CFC asthma inhalers using Zephex 134a

The US Food and Drug Administration has approved GlaxoSmithKline'sVentolin HFA (albuterol sulfate), a new version in a metered-dose inhaler, using INEOS Fluor's Zephex 134a medical propellant, for the treatment of asthma and other obstructive lung diseases. INEOS notes that this FDA approval paves the way for Zephex 134a to be used in around a quarter of the world's metered-dose inhalers by the end of this year.

INEOS also notes that a recent inspection of the Zephex 134a manufacturing facilities by the UK Medicines Control Agency has confirmed that the standard of current Good Manufacturing Practice is at a level suitable for the manufacture of active pharmaceutical materials.

It adds that the Ventolin HFA inhaler, already adopted in Europe, uses hydrofluoroalkane instead of chlorofluorocarbon as a propellant. Although no action to remove the albuterol CFC inhalers from the US market is planned at this time, INEOS says the availability of HFA inhalers now offers an alternative.