Xopenex pediatric use
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA approves Sepracor's inhalation solution Xopenex (levalbuterol) Jan. 31 for treatment or prevention of bronchospasm in children six to 11 years old with reversible obstructive airway disease. The agent will also be marketed in a new 0.31 mg strength for pediatric use. Xopenex has been approved for use in patients 12 and older since 1999. The company submitted the sNDA in March 2001 for use in children as young as fou