Scios (SCIO, $21, down 4%) announced that it has received a letter from the U.S. FDA stating that the company’s New Drug Application for Natrecor is approvable. To finalize the approval process, Scios and the FDA need to define the labeling for Natrecor and complete a pre-approval inspection. Scios has developed Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure (CHF). The company expects to launch the drug in the third quarter of this year.
Natrecor is a recombinant form of B-type natriuretic peptide -- a
naturally occurring hormone in the body that aids in the healthy
functioning of the heart. When approved by the FDA, Natrecor will become the first new treatment for acutely decompensated CHF in more than a decade. Roughly five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute CHF.
Taken from the Bull Market write this morning!
muel <g>
