U.S. Food and Drug Administration and Xanodyne Agree on a Plan to Keep Propoxyphene-Containing...

U.S. Food and Drug Administration and Xanodyne Agree on a Plan to Keep
Propoxyphene-Containing Products Available as Treatment Options for the
Management of Mild to Moderate Pain

NEWPORT, Ky., July 7 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. has
reached an agreement with the FDA to keep propoxyphene-containing products
Darvon(R) (propoxyphene hydrochloride), Darvon-N(R) (propoxyphene napsylate),
Darvocet-N(R) 50 & Darvocet-N(R) 100 (propoxyphene napsylate and
acetaminophen) available as treatment options for the management of mild to
moderate pain. This action follows a joint committee meeting with the U.S.
Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory
Committee (ALSDAC) and Drug Safety and Risk Management Advisory Committees
(DSRMAC) that was held on January 30, 2009.

The action by the FDA requires the manufacturers of propoxyphene-containing
products to address three primary areas; change the product label to
strengthen important safety information about overdose and certain drug-drug
interactions, develop and distribute a patient medication guide and provide
additional clinical data to further evaluate cardiac safety.

"This is an important decision by the agency which demonstrates the value of
these products for patients who suffer from pain. We will work diligently with
the agency in the coming months to ensure compliance with the items referenced
in the ruling," said Michael Valentino, President and Chief Executive Officer.

Xanodyne is committed to supporting the appropriate use of its medications
according to FDA-approved product labeling. The diverse nature of pain and the
difficulty in appropriately treating patients underlies that physicians and
patients must have available numerous therapeutic options, including
propoxyphene, for effective management of mild to moderate pain.

The most frequently reported side effects of propoxyphene-containing products
include dizziness, sedation, nausea, and vomiting. Constipation, abdominal
pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria,
hallucinations, and minor visual disturbances have also been reported. For
additional important safety and dosing information, please see the full
prescribing information at www.xanodyne.com.

About Xanodyne
Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an
integrated specialty pharmaceutical company with both development and
commercial capabilities focused on women's healthcare and pain management.
Xanodyne markets a portfolio of products consisting of prescription
pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is
advancing a late stage pipeline of product candidates targeted at significant
potential markets in Xanodyne's focus areas.

SOURCE Xanodyne Pharmaceuticals, Inc.

Tom Jennings of Xanodyne Pharmaceuticals, Inc., +1-859-371-6383