04/19/2010 - Graceway Pharmaceuticals, LLC announced that the Food and Drug Administration (“FDA”) published a long-awaited Final Rule regarding the continued availability of Maxair Autohaler (pirbuterol acetate inhalation aerosol) and other pressurized metered-dose inhalers containing chlorofluorocarbons (CFCs). Under the rule, Maxair Autohaler will remain available for physicians and patients through December 31, 2013.
In support of its decision, FDA noted that it received a large number of comments from physicians and patients addressing the public health benefits of pirbuterol – the active ingredient in Maxair Autohaler. FDA likewise observed that the need for patient education was an important factor in extending the effective date of the rule, and the Agency committed to actively monitor the patient transition to CFC-free alternatives... Graceway Pharmaceuticals' Press Release -
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