www.fdanews.com/articles/70066-fda-approves-sepracor-s-xopenex-hfa-metered-dose-inhaler
FDA Approves Sepracor's Xopenex HFA Metered-Dose Inhaler
March 21, 2005
The FDA has approved Sepracor's new drug application for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane metered-dose inhaler for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease.
Reversible obstructive airway disease includes respiratory disorders such as asthma and chronic obstructive pulmonary disease.