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FDA Proposes Removing Essential Use for Inhaler Ingredients

06/11/2007

Federal Register Proposed rule: FDA is proposing to amend its regulation on the use of ozone-depleting substances in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. If the applicable essential-use designations are removed, MDIs containing these substances could not be marketed after a suitable transition period. To view this proposed rule, click here.

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