Environment
This article was originally published in SRA
Executive Summary
US extends consultation period for proposed ban on metered-dose inhaler aerosols
US extends consultation period for proposed ban on metered-dose inhaler aerosols
The US Food and Drug Administration (FDA) has extended the period for a public consultation on its proposed rule to ban seven metered-dose inhaler (MDI) aerosols that use chlorofluorocarbon (CFC) propellants1,2. The decision was made in response to a request by a manufacturer of a pirbuterol MDI, which uses an ozone-depleting substance as a propellant. As a result, the agency is now accepting comments until 10 September 2007. The original comment deadline was 10 August 2007.
The proposed rule would remove from the market the following products: Aerobid and Azmacort, which respectively contain the corticosteroids flunisolide and triamcinolone; Alupent and Maxair, which respectively contain the short-acting beta2-adrenergic agonists metaproterenol and pirbuterol; Intal and Tilade, which contain cromolyn and nedocromil, respectively; and Combivent, which contains both the fast-acting beta2-adrenergic bronchodilator salbutamol (albuterol) and the longer-acting anticholinergic bronchodilator ipratropium. The FDA says that therapeutic alternatives that do not use an ozone-depleting substance are currently on the market.
References
1. Federal Register, 7 August 2007, 72(151), 44037-44038
2. The Regulatory Affairs Journal - Pharma,2007, 18(7), 495-496