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.
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.|
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