Abbott/Orion Simdax
Executive Summary
NDA submitted in late 1998 for calcium sensitizer levosimendan for short-term intravenous treatment of decompensated heart failure. Orion's NDA includes data from two studies in approximately 1,000 patients, Orion said. Studies have also been completed in heart failure after an acute myocardial infarction and comparing Simdax to dobutamine. Orion will manufacture the product, which Abbott will market worldwide