3M says it has cooperated with the FDA and invested in its facilities in preparation of the phase-out of CFC containing metered dose inhalers (MDIs).
The US Food and Drug Administration (FDA) has published an update informing users that the remaining two inhalers for the treatment of asthma and chronic obstructive pulmonary disease (COPD) containing chloroflurocarbons (CFCs), will soon be taken off the market.
The Combivent Inhalation Aerosol - marketed by Boehringer Ingelheim - will no longer be available after July 31, whilst a deadline of the end of the year has been placed on the Maxair Autohaler. Both are manufactured by 3M at its Northridge, California facility.
Speaking with this publication, 3M Communications Manager Rosalind Smith said “as with all of its pharmaceutical partners, 3M has worked in close cooperation with the marketing authorisation holders on their plans to phase out CFC-containing asthma inhalers, in compliance with global legislation.”
Smith continued, adding that “going forward, 3M has recently made a significant investment in pressure filling manufacturing capability at Northridge to complement its existing cold filling capability, ensuring 3M remains at the forefront of metered dose inhaler manufacturing.”
Expansion came last year at the 300,000 sq. ft. facility, allowing the manufacture of new, non-CFC pressurised MDIs on a global scale. The company’s drug delivery unit also has facilities in Loughborough, UK and Hurlingham, Argentina.
Finally CFC Free
The FDA has for some time been targeting MDIs containing CFCs in response to The Montreal Protocol on Substances that Deplete the Ozone Layer , published in 2000, and the US Clean Air Act which has banned CFC production and importation since 1996 on all products except those deemed medically essential with no suitable alternative.
A phase out was originally proposed in 2004 , and the following year the FDA set a deadline of the end of 2008 for the complete end of production of albuterol inhalers using CFCs as propellants, replacing them with alternatives that use hydrofluoroalkanes (HFAs) as a propellant.
According to the regulatory body, the US has more than 25m people who suffer from asthma and an additional 15m have been diagnosed with COPD.
The end of production of the two MDIs should not, however, cause a problem for users of the devices. Boehringer Ingelheim’s Combivent Respimat is a CFC-free alternative to the Combivent Inhalation Aerosol, whilst the FDA has a continuously updated list of alternatives approved products on the market that don’t contain CFCs for users of the Maxair Autohaler.