What Is the Availability of CFC-Free Albuterol Inhalers?
What Is the Availability of CFC-Free Albuterol Inhalers?
The shortage of albuterol inhalers is becoming acute. When is it anticipated that the "new" albuterol inhalers (chlorofluorocarbon [CFC]-free) will be available in sufficient supply?
The recent limited availability of albuterol metered-dose inhalers is a result of changes in propellant standards, requiring manufactures to convert from CFC to non-CFC propellants. This change was outlined in an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer, which banned the use of CFC propellants in consumer aerosol products. The agreement did allow developed countries to continue using CFC propellants for medical products that were determined to be medically necessary. Based on this exception, the United States received permission to continue manufacturing albuterol inhalers containing CFCs as well as other inhalers for asthma and chronic obstructive pulmonary disease.
In March 2005, the US Food and Drug Administration announced that albuterol inhalers using CFC propellants should no longer be produced, marketed, or sold in the United States after December 31, 2008. This was based on a re-evaluation of the current albuterol inhaler market, which found that inhalers with CFCs were no longer medically necessary.
Currently, there are 3 albuterol metered-dose inhalers marketed in the United States that use a non-ozone-depleting propellant, hydrofluoroalkane (HFA): Proventil HFA (Schering-Plough); Ventolin HFA (GlaxoSmithKline); and IVAX albuterol sulfate HFA (IVAX Corp). However, only Proventil HFA and Ventolin HFA should be formally considered alternative products because the newer IVAX product lacks adequate postmarketing data.
Based on current information, the availability of albuterol HFA products is as follows:
The CFC-containing albuterol inhalers are also in short supply. Their status is as follows:
The bottom line is that there are only 3 albuterol manufacturers currently providing an albuterol HFA product. There is concern that these manufacturers cannot meet the current and future market demand. If no additional manufacturers join the albuterol HFA market, supply limitations may continue. At this time, no generic manufacturers have applied to market an albuterol HFA inhaler. The possibility remains that periodic shortages of albuterol HFA will continue.
Question
The shortage of albuterol inhalers is becoming acute. When is it anticipated that the "new" albuterol inhalers (chlorofluorocarbon [CFC]-free) will be available in sufficient supply?
Response from the Expert Mario Tanzi, BS, PharmD
The recent limited availability of albuterol metered-dose inhalers is a result of changes in propellant standards, requiring manufactures to convert from CFC to non-CFC propellants. This change was outlined in an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer, which banned the use of CFC propellants in consumer aerosol products. The agreement did allow developed countries to continue using CFC propellants for medical products that were determined to be medically necessary. Based on this exception, the United States received permission to continue manufacturing albuterol inhalers containing CFCs as well as other inhalers for asthma and chronic obstructive pulmonary disease.
In March 2005, the US Food and Drug Administration announced that albuterol inhalers using CFC propellants should no longer be produced, marketed, or sold in the United States after December 31, 2008. This was based on a re-evaluation of the current albuterol inhaler market, which found that inhalers with CFCs were no longer medically necessary.
Currently, there are 3 albuterol metered-dose inhalers marketed in the United States that use a non-ozone-depleting propellant, hydrofluoroalkane (HFA): Proventil HFA (Schering-Plough); Ventolin HFA (GlaxoSmithKline); and IVAX albuterol sulfate HFA (IVAX Corp). However, only Proventil HFA and Ventolin HFA should be formally considered alternative products because the newer IVAX product lacks adequate postmarketing data.
Based on current information, the availability of albuterol HFA products is as follows:
Schering-Plough has shipped Proventil HFA (NDC 00085-1132-01) to wholesalers.
GlaxoSmithKline has discontinued its Ventolin product line, and its Ventolin HFA is not currently available.
IVAX has made its albuterol HFA inhaler (NDC 59310-579-20) available to order through wholesalers.
The CFC-containing albuterol inhalers are also in short supply. Their status is as follows:
Schering-Plough has shipped Proventil (NDC 000850614-02) to wholesalers.
Schering-Plough is allocating supplies of the Warrick albuterol inhaler (NDC 59930-1560-01) to wholesalers and does not provide an estimate for routine availability of its inhalers.
IVAX also is allocating albuterol CFC inhalers (NDC 00172-4390-18) to wholesalers and does not estimate a release date for routine supplies.
Andrx (NDC 62037-0794-44) has limited supplies of product available. Customers who have an account with Anda may obtain Andrx inhalers only if they buy other Anda products.
Armstrong Pharmaceuticals has limited supplies available (NDC 17270-0721-01) and is shipping product to wholesalers as it becomes available.
Pliva (formerly Sidmak) discontinued its albuterol inhaler in June 2004.
The bottom line is that there are only 3 albuterol manufacturers currently providing an albuterol HFA product. There is concern that these manufacturers cannot meet the current and future market demand. If no additional manufacturers join the albuterol HFA market, supply limitations may continue. At this time, no generic manufacturers have applied to market an albuterol HFA inhaler. The possibility remains that periodic shortages of albuterol HFA will continue.
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