Abbott has received a complete response letter from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for a controlled-release form of hydrocodone with acetaminophen. Abbott is evaluating the FDA complete response letter, will discuss the letter with the FDA, and will provide an update when appropriate.
Abbott is seeking the approval of controlled-release hydrocodone with acetaminophen as the first extended release medication in the class to provide extended relief over 12 hours; currently available short-acting hydrocodone and acetaminophen (HC/APAP) medications must be taken every four to six hours.
Abbott is confirming its earnings-per-share forecast for the fourth quarter and full-year 2008. In addition, the company continues to expect double-digit earnings-per-share growth in 2009.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.