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:3/28/2017)... ... 2017 , ... With less than 10,000 dermatologists in the United States and ... limited while the desire to conquer breakouts and eliminate skincare stress is widespread. ... online, today released its inaugural survey on the State of Acne in America. ...
(Date:3/28/2017)... Petersburg Florida (PRWEB) , ... March 28, 2017 , ... ... Marine Corp to raise money to for the Toys for Tots Literacy Campaign at ... federal budget in excess of $70 billion, the U.S. ranks at number 14 internationally ...
(Date:3/28/2017)... ... March 28, 2017 , ... AutismOne announced the Board Certified ... Integrative Medicine and available for application on Saturday, May 27, 2017, following Thursday, ... Colorado Springs. , Ed Arranga, president of AutismOne, stated: "Many of the modalities ...
(Date:3/28/2017)... NJ (PRWEB) , ... March 28, 2017 , ... ... Camp Association’s Tri-State Camp Conference in Atlantic City March 13-16, was a busy ... their team of professional staff discussed strategies for preventing outbreaks among camp communities ...
(Date:3/28/2017)... ... March 28, 2017 , ... Oily skin is a common and unwelcomed occurrence in ... has a lot to offer to the discussion of dealing with excess skin oil. ... there are many home remedies that can help remove the oily shine while keeping the ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... 27, 2017 Medtec Europe ... more than 600 exhibitors from 70 countries the ... solutions that will advance the medical technology industry. ... the Messe Stuttgart, Stuttgart, Germany ... platform showcasing the key trends and insights across ...
(Date:3/27/2017)... March 27, 2017  Sophiris Bio Inc. (NASDAQ: ... a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) ... today reported fourth quarter and full year 2016 ... Key Corporate Highlights: Advanced ... Cancer. During 2016, the Company reported successful results ...
(Date:3/27/2017)... VANCOUVER , March 27, 2017 /PRNewswire/ - INVICTUS ... OTC: IVITF; FRA: 8IS) Invictus MD is pleased to ... common shares for trading on the TSX Venture Exchange.  ... the TSXV follows a year of significant achievements for ... The successful test crops at AB Laboratories Inc. ("AB ...
Breaking Medicine Technology: