FDA rejects extended release Vicodin

[cougarnurse]

From the Chicago Tribune: FDA rejects Abbott's extended-release Vicodin -- chicagotribune.com

The U.S. Food and Drug Administration did not approve Abbott Laboratories' extended-release formulation of the painkiller Vicodin, the North Chicago-based drug giant confirmed Monday afternoon.

The FDA's decision to issue a "complete response letter," essentially a rejection of Abbott's product, comes amid a period of intense scrutiny by the federal agency, lawmakers and consumer groups on drug approvals, particularly pain killers. In 2004, for example, Merck & Co. pulled the pain killer Vioxx from the market after studies showed users had an increased risk of heart attacks and strokes. In the wake of that decision, the FDA has faced much criticism for approving Vioxx.

"Abbott is evaluating the FDA Complete Response Letter, will discuss the letter with the FDA and will provide an update when appropriate," Abbott said in a statement issued after the close of trading on the New York Stock Exchange.

Abbott was 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," the company said. Currently available "short acting" versions must be taken every four to six hours. Some doctors and consumer groups have also voiced concerns over the potential for abuse of pain killers such as Vicodin.

The FDA could not be reached this afternoon for comment.

Abbott had been projecting the controlled-release formulation of Vicodin would eventually reach $500 million in annual sales. Abbott has total annual sales of more than $26 billion.

Despite the FDA's letter, Abbott Monday confirmed its earnings forecast for the fourth quarter and full-year 2008, saying it "continues to expect double-digit earnings per share growth in 2009."