FDA Schedules PhaseOut of CFC Metered-Dose Inhalers

4/15/2010
The FDA has announced that 7 metered-dose inhalers (MDIs) containing ozone-depleting chlorofluorocarbons (CFCs) will be gradually removed from the US marketplace in accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer. The inhalers are used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the US marketplace. The affected MDIs and their phase-out dates include Tilade (nedocromil sodium; 6/14/2010) and Alupent (metaproterenol sulfate; 6/14/2010), Azmacort (triamcinolone acetonide; 12/31/2010) and Intal (cromolyn sodium; 12/31/2010), Aerobid (flunisolide; 6/30/2011), and Maxair (pirbuterol acetate; 12/31/2013). Boehringer Ingelheim Pharmaceuticals’ Combivent (ipratropium bromide and albuterol sulfate) was granted "essential use" status by the FDA and will remain available in its current CFC-containing formulation until December 31, 2013. Boehringer Ingelheim is currently working on a CFC-free replacement product that is in late-stage clinical development and is expected to be available prior to the December 2013 deadline. Patients using CFC-containing inhalers scheduled to be phased out should continue their current inhaler medication, but should discuss alternative treatment with their health care provider.
Clin-eguide™ is an online clinical decision support tool that provides the most accurate evidence-based information for health care providers in the clinical setting. It integrates trusted content from Ovid, Facts & Comparisons®, and Lippincott Williams and Wilkins, as well as other premier publishers.