SYMBICORT was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2006. The SYMBICORT submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a pMDI. The approved indication is largely based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the U.S., age 12 and older. These studies showed that both dosage strengths of SYMBICORT produced a greater improvement in lung function compared to the same doses of budesonide or formoterol, administered alone, or placebo. In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Clinically significant improvement in bronchodilatory response, or opening of the lung airways, occurred within 15 minutes of beginning treatment with SYMBICORT.

The safety profile of SYMBICORT is based on a robust U.S. development program, which evaluated safety in over 6,000 patients treated with SYMBICORT in Phase I, II and III studies that were submitted to the FDA. SYMBICORT has safety data from long-term studies up to one year and a robust cardiac safety profile.