The agency sent the drugmaker a 'complete response letter,' which is another way of saying its extended-release formation of Vicodin is not being approved.
Abbott wanted to sell a pill containing controlled-release hydrocodone and acetaminophen as the "first extended release medication in the class to provide extended relief over 12 hours," according to a statement. Existing "short-acting" versions of the painkiller must be taken every four to six hours, which have been the object of abuse.
Meanwhile, Abbott is "evaluating" the FDA response, without giving any further indication of what steps may be taken. Nonetheless, the drugmaker confirmed its earnings forecast for the fourth quarter and 2008, saying it "continues to expect double-digit earnings per share growth in 2009." The new version of Vicodin, by the way, was projected to generate more than $500 million in annual sales.