Ozone depletion changes will affect asthma drug supplies

Ozone layer/ greenhouse effect chemicals are almost phased all out now and the latest changes will affect some asthma sufferers.

Compliance with the Montreal Protocol (Article 2F) clean air treaty by the United States Food and Drug Administration (FDA) will force leading metered-dose inhalers (MDI's) containing ozone-depleting propellants (chlorofluorocarbon's (CFC's)) off the U.S. asthma treatment market by the end of 2008. FDA Reg. 21 CFR 2.125 has been amended to cease the production and use of ozone-depleting substances (ODSs) in asthma producst products, which had been exempt long ofater other non essential products such hair sprays etc.,. This regulation change establishes December 31, 2008, as the date by which production and sale of single ingredient albuterol CFC MDIs must stop.

Because all current generic versions of inhaled albuterol contain ozone-depleting chlorofluorocarbon (CFC) propellants, generics will be removed from the U.S. market by 2008. That means higher-priced ( approx US$20 more per metered dode inhaler than generics using CFC) branded albuterol's propelled with hydrofluoroalkane (HFA) (1/3rd the one third of the 'greenhouse' (global warming) effect of the CFCs it replaces),with the result that the U.S. supplies will become branded only. Leading to $1 billion in major market sales for GlaxoSmithKline's Ventolin and Schering-Plough's Proventil to enable access these manufacturers intend to include in their sales prgrams, MDI giveaways, coupons for reducing the price paid and patient-assistance programs based on financial need. However the FDA is already reporting supply problems as manufacturers phase out the HFC product.

More doctors will possibly use nebulized levalbuterol as an alternative to albuterol, which could generate more sales for Sepracor's Xopenex (levalbuterol) but this is unsuitable for children under six years of age.

American generic manufacturer IVAX was taken over by Israel's biggest company last year, TEVA to make the worlds biggest generic company with combined sales to the US market of 330 drugs and sales of US$7 Bn (of which US$1.2 Mn is MS treatment Copaxone); the US HQ will be in Kansas City. They say they will be producing an albuterol with HFA ... real soon.

TEVA recently announced upping their stake in Tienjin, China, based Hualida Biotechnology Co., Ltd. to 60%.

For more information and FAQ's from FDA go here see your doctor or find out more here. Do it NOW for yourself or yuor family.... NOW

Proventil-HFA (NDC 00085-1132-01) Schering Customer Service: 1-877-432-7768.
Ventolin-HFA (NDC# 0173-0682-00) GlaxoSmithKline -Customer service number 1-888-825-5249
Albuterol-HFA (NDC 59310-579-20) from IVAX as it becomes available

Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol metered dose inhalers (NDC 63402-510-01). Sepracor - Customer service 1-888-394-7377

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Pulmicort(R) HFA-MDI
This new HFA-powered MDI containing AstraZeneca's inhaled
corticosteroid Pulmicort(R) (budesonide) was filed for marketing
authorization in June 2005 on a country-by-country basis in Europe for the
treatment of asthma in adults and children. SkyePharma developed this new
HFA-MDI formulation, which employs its proprietary formulation technology,
and also conducted the clinical development programme for AstraZeneca.

In February 2006, the product received approval in Finland, its first European market. This product has not yet been approved for use by the US Food and Drug Administration.