Although most inhaler products containing CFCs have already been phased out by the FDA, two products currently remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler
General information about Maxair Autohaler
(pirbuterol acetate inhalation aerosol).
One alternative to overcome the difficulty of simultaneously actuating and inhaling from an MDI is to use a breath-actuated MDI, such as 3M's Maxair Autohaler
Graceway Pharmaceuticals, LLC today 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).
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.
Maxair Autohaler is the only MDI that uses pirbuterol as its active ingredient.
Maxair Autohaler is indicated for prevention and reversal of bronchospasm in patients aged 12 years and older with reversible bronchospasm including asthma.
Maxair Autohaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.
Maxair Autohaler can produce paradoxical bronchospasm, which can be life threatening.
Under the agreement, Graceway Pharmaceuticals will acquire exclusive regional marketing and intellectual property rights for 3M's well-known branded pharmaceuticals, including Aldara, Tambocor, Maxair Autohaler
, MetroGel-Vaginal and Minitran.
This recall does not affect Maxair Autohaler (pirbuterol acetate inhalation aerosol), a breath-actuated metered-dose inhaler.
3M will provide Maxair autohaler (pirbuterol acetate inhalation aerosol), a breath-actuated inhaler (200 mcg pirbuterol/ inhalation), free of charge in exchange for the Maxair press-and-breathe inhaler (200 mcg pirbuterol/inhalation).