BRISTOL, Tenn.– published a -awaited Final Rule regarding the continued availability of Maxair Autohaler and other pressurized metered-dose inhalers containing chlorofluorocarbons . Under the rule, Maxair Autohaler will remain available for physicians and patients through December 31. 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 Maxair Autohaler. FDA likewise observed that the need for patient education was important factor extending the effective date of the rule, and the Agency committed to actively monitor the patient transition to CFC-free alternatives. Graceway’s Chairman and CEO, J. , stated, We are extremely pleased that the FDA has allowed Maxair to remain on the market while we continue our development efforts for a CFC-free formulation. This means that patients who rely on Maxair can continue to use it for the unique benefits it provides asthma rescue therapy. Details of FDA’s final rule can be found the April 14 issue of the Federal Register, and FDA has also posted more information on its website, available at http: NewsEvents Newsroom PressAnnouncements ucm208302.htm The Only MDI with Pirbuterol Maxair Autohaler is the only MDI that uses pirbuterol as its active ingredient. As a pharmacologically distinct medication, pirbuterol provides alternative to albuterol for patients needing asthma rescue therapy. About Maxair Autohaler Maxair Autohaler is indicated for prevention and reversal of bronchospasm patients aged 12 years and older with reversible bronchospasm including asthma. It be used with or without concurrent theophylline and or corticosteroid therapy. IMPORTANT SAFETY INFORMATION Maxair Autohaler is contraindicated patients with a history of hypersensitivity to pirbuterol or any of its ingredients. Maxair Autohaler, like other inhaled beta-adrenergic agonists, can produce a clinically significant cardiovascular effect some patients, as measured by pulse rate, blood pressure, and or other symptoms. Although such effects are uncommon after administration of Maxair Autohaler at recommended doses, if they occur, the drug need to be discontinued. addition, beta agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Maxair Autohaler, like all sympathomimetic amines, should be used with caution patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Maxair Autohaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, Maxair Autohaler should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. The use of beta-adrenergic agonist bronchodilators alone not be adequate to control asthma patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids. The following adverse reactions were reported more frequently than 1 100 patients: nervousness , tremor , headache , dizziness , palpitations , tachycardia , cough , and nausea . About Graceway Pharmaceuticals ®, LLC Graceway Pharmaceuticals ®, LLC , headquartered Bristol, TN, is a pharmaceutical company focused on acquiring, -licensing, and developing branded prescription pharmaceutical products. Graceway initially acquired Maxair Autohaler as part of its acquisition of ‘s branded pharmaceutical business the United States, Puerto Rico, Canada and Latin America. Graceway has also recently completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. and Gilead Sciences, Inc. . Current prescription products marketed by Graceway include Aldara ® Cream, 5%; Maxair ® Autohaler ® ; Atopiclair ® Nonsteroidal Cream; and Estrasorb ® . Aldara ®, Maxair ®, Autohaler ®, Atopiclair ®, and Estrasorb ® are trademarks owned by or licensed to Graceway. For more information on Graceway’s products, including important safety information, please visit .