Acton Pharmaceuticals Inc, Marlborough, Mass, announced that the US Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) 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 now plans to launch AEROSPAN in early 2013 into the US market.
AEROSPAN was developed with an integrated spacer device and, according to the company, has been studied in clinical trials involving more than 1,700 patients. The AEROSPAN New Drug Application (NDA) was acquired by Acton in 2009 under a licensing agreement with Forest Laboratories Inc, at which time Acton assumed all responsibilities associated with the development and commercialization of AEROSPAN.
Source: Acton Pharmaceuticals Inc