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.
75%, Aldara (imiquimod) Cream, 5%, Maxair Autohaler
(pirbuterol acetate inhalation aerosol), Atopiclair Nonsteroidal Cream, and Estrasorb (estradiol topical emulsion).
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.
Maxair Autohaler is indicated for the prevention and reversal of bronchospasm in patients with reversible bronchospasm including asthma.
The agreement will add RPR's 864 sales representatives to 3M's 212 representatives currently promoting Maxair Autohaler, significantly enhancing physician awareness of the product.
Maxair Autohaler satisfies the need to provide cost-effective medications while still offering patients the newest technology.
Maxair Autohaler can be used with or without concurrent theophylline and or steroid therapy.
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).