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
Date:7/7/2009

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.
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:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... February 11, 2016 , ... According to an article published February ... loss dietary supplement, is being recalled due to the discovery that it contains dangerous ... not a single supplement on the market proven to help people safety lose excess ...
(Date:2/11/2016)... , ... February 11, 2016 , ... Registered nurses, licensed ... CEU seminar titled, “Stroke Management: Time to Act, Time to Heal” on Thursday, February ... in Whippany, N.J. The presenter is Vishal Chedda, president of ANSA Consultants, who will ...
(Date:2/11/2016)... (PRWEB) , ... February 12, 2016 , ... The ... is up from 0.416 in 2013. The SJR uses data taken from the Scopus ... account both the number of citations received by the journal over a three year ...
(Date:2/11/2016)... ... 11, 2016 , ... The Chartis Group, a national advisory ... in the “2015/2016 Best in KLAS: Software and Services” report in two categories: ... and insights firm on a global mission to improve healthcare delivery by amplifying ...
(Date:2/11/2016)... ... February 11, 2016 , ... Thermi™, a world leader ... to announce the promotions of Allison Kelly to executive vice president of the ... vice president of North American capital sales, and Wendy Oseas to vice president ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016 Potrero ... system, is pleased to announce the appointment of George ... San Antonio, TX , WellMed is ... servicing over 200,000 patients and HMO members in ... founding WellMed in 1990 out of his own internal medicine ...
(Date:2/11/2016)... Feb. 11, 2016  MiMedx Group, Inc. (NASDAQ: ... amniotic membrane and other birth tissues, human skin and ... and market advanced products and therapies, announced today that ... Global Healthcare Conference in New York ... Michael J. Senken , Chief Financial Officer and ...
(Date:2/11/2016)...  AfterPill.com is reporting that this week,s Centers for ... women who are at risk of unintended pregnancy impacts ... raises the risks of unprotected sex in particular.  ... to the Guttmacher Institute, there are 43 million women ... who have sex without the intention of becoming pregnant.  ...
Breaking Medicine Technology: