Ivax breath-activated HFA albuterol “approvable”
Executive Summary
Ivax' breath-activated hydrofluoroalkane-propelled albuterol gets "approvable" letter from FDA, the company announces July 7. Ivax markets the breath-activated device as Easi-Breathe in Europe. Members of FDA's Pulmonary-Allergy Drugs Advisory Committee suggested delaying a chlorofluorocarbon ban to allow time for Ivax' and Sepracor's Xopenex HFA (levalbuterol) products to reach market (1"The Pink Sheet" June 21, 2004, p. 42)...