Navigation Links
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

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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. VNUS Medical Technologies Announces Resignation of Chief Financial Officer and VP, Finance & Administration
2. Office of Administration Announces Plan to Preserve Health Care Benefits for Current, Future Retired Commonwealth Employees
3. Wells Fargo Offers Online Benefit Administration for Business and Individual Healthcare Consumers
4. Administration Anesthetized to Ailments of Nations Children
5. Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract
6. Siemens Medical Solutions Receives CCHIT Certification for Soarian Clinicals With Siemens Pharmacy and Med Administration Check
7. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
8. Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
9. Chip PC Wins Europes Largest Thin Client Tender to Supply 20,000 Thin Clients and Management Software to German RZF - Financial Administration of North Rhine-Westphalia County
10. ActiPatch(TM) Granted Market Clearance by the Food & Drug Administration in the Kingdom of Jordan
11. ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration
Post Your Comments:
(Date:11/24/2015)... ... ... Young patients with a wide variety of dental needs can now receive ... who are pediatric dentists in Tucson, AZ . Unlike traditional treatment options that ... minimal discomfort and bleeding to the patient during treatment and the following recovery period. ...
(Date:11/24/2015)... ... ... DMG Productions announced that they will feature Aphria, Inc., in an upcoming episode ... and show times TBA. , Aphria, Inc., is a publicly traded company incorporated under ... medical marijuana pursuant to the Marijuana for Medical Purposes Regulations (the “MMPR”). , Aphria ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Bolier Reactor System. Brillouin is the developer of renewable energy technologies capable of ... nuclear reactions (“LENR”), announced today that its WET™ and HHT™ Boiler System reactor ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Family Care (AFC), the nation’s ... a holiday pop-up clinic located in Metro Atlanta’s North Point Mall. The clinic is ... different way. The location is scheduled to operate through Dec. 24. , Holiday Pop-Up ...
(Date:11/24/2015)... ... November 24, 2015 , ... Abington Hospital – Jefferson Health ... Quality® Bariatric Surgery Facility for treating individuals living with morbid or extreme obesity. ... available to its members to help them make informed decisions about their healthcare ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , 24 de noviembre de 2015 /PRNewswire/ ... Breathing Pacemaker System, se complace anunciar el nombramiento ... consultor clínico.   ... -   --> ... un fisiólogo y consultor en neonatología y cardiología ...
(Date:11/24/2015)... 2015  DILON Diagnostics and GE Healthcare are pleased ... DILON to distribute GE,s Discovery NM750b Molecular Breast Imaging ... this distribution agreement will provide Dilon,s experienced distribution network ... and is considered an initial step in an ongoing ... clinicians and their patients. --> ...
(Date:11/24/2015)... Sectra (STO: SECT B) announces that ... agreement to deploy Breast Imaging PACS in its ... Breast Center a future-proof platform capable of expanding with the ... that Breast Center of Acadiana has entered into ... in its two freestanding imaging centers. This investment will ...
Breaking Medicine Technology: