FDA approves Acton’s AEROSPAN sNDA to treat asthma

Published on September 21, 2012 at 3:45 AM · No Comments

Acton Pharmaceuticals, Inc. (Acton) announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) for AEROSPAN® (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older. With this approval, Acton is now planning to launch AEROSPAN in early 2013 into the $8.3 billion U.S. inhaled steroid market.    

The Centers for Disease Control (CDC) estimates that more than 24 million Americans have asthma and of these, more than half have an asthma attack each year. Annually, the disease is responsible for nearly two million emergency room visits and accounts for an estimated $11.5 billion in health care costs. When taken every day, maintenance inhalers like AEROSPAN can help prevent the wheezing coughing, and tightening of the airways, which causes shortness of breath and can be life threatening.

"Preventing asthma attacks remains a significant hurdle in the treatment of asthma patients," said William E. Berger, M.D., Clinical Professor, Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine. "The FDA approval for AEROSPAN will provide patients with an effective new treatment option and it's exciting that physicians will be able to prescribe an inhaled steroid with a unique, built-in delivery system that is designed to make it easy for patients to inhale their aerosol medication."

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