The only asthma inhaler sold without a prescription in the US will be banned next year, as part of the international agreement to phase out CFCs, which destroy the Earth’s ozone layer.
The Food and Drug Administration (FDA) announced that Primatene Mist, an over-the-counter epinephrine inhaler that provides temporary relief for mild symptoms of asthma, will be banned because the chlorofluorocarbons (CFCs) used to propel the medication depletes the earth’s ozone layer.
The order complies with the terms of the Montreal Protocol, the hugely successful international agreement that bans ozone-depleting substances worldwide.
The FDA phased out the use of CFCs in inhalers in 2008; Primatene Mist inhalers are labeled to indicate they can’t be used after December 31, 2010.
CFCs were used in a wide variety of consumer products from hairspray to deoderants until they were banned in the 1970s, but have been allowed to continue in some medical products until now. Two prescription inhalers that still use CFCs will be phased out by their manufacturers in 2013.
Manufacturers found they could easily develop substitutes that worked just as well, once the Montreal Protocol went into force.
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Armstrong Pharmaceuticals, Inc. is actively finalizing its internal
development of a new,
CFC-Free Primatene*Mist that will continue to use epinephrine as its active
ingredient but will use a more environmentally friendly propellant (known as
HFA, or hydrofluoroalkane). There will likely be a period of time between
December 31, 2011 and the date of FDA Approval of the new HFA Primatene*Mist
product. Please be assured that Armstrong Pharmaceuticals, Inc. is committed
to bringing the new product to market in the shortest time possible once the
product is approved by the FDA>