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:10/13/2017)... ... October 13, 2017 , ... The American Board of ... its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his ... July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... Bethesda, MD (PRWEB) , ... October 12, 2017 , ... ... Award of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s ... 4 – 8. , In honor of Morris F. Collen, a pioneer in the ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 /PRNewswire/ ... and OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... a strategic hub service that expedites and streamlines patient ... spirometer, Spiro PD 2.0, and wellness management services.  ... a medical device used to measure lung function for ...
(Date:9/13/2017)... has been named the official orthopedic and sports medicine ... 2018 College Football Playoff (CFP) National Championship to be played ... Atlanta, Georgia . OrthoAtlanta is proud to be ... many activities leading up to, and including the national championship ... OrthoAtlanta serves ...
(Date:9/12/2017)...  Consumer reviews on the independent review site Consumer Affairs ... company for hearing aids, ranking it higher than Miracle Ear ... ... For Hearing Aids ... online store that provides high performance, state-of-the-art, German-engineered hearing aids directly ...
Breaking Medicine Technology: