Navigation Links
Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
Date:4/2/2009

NEWPORT, Ky., April 2 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review status for its investigational proprietary formulation of tranexamic acid for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms. On January 30, 2009, Xanodyne submitted the New Drug Application (NDA) for XP12B, a unique oral therapy which acts as a competitive plasmin inhibitor to prevent fibrinolysis by binding to the lysine receptor sites of plasminogen. This helps to normalize the hyperfibrinolytic activity often present in women with HMB.

"We are pleased with the position that the FDA has taken in granting XP12B a priority review as it reflects their recognition of the important unmet medical need which HMB represents. We look forward to working closely with the agency to further advance this important treatment option to women who suffer from menorrhagia, or heavy menstrual bleeding," said Gary A. Shangold, Chief Medical Officer of Xanodyne.

Under the Prescription Drug User Fee Act (PDUFA), drug products with priority review designation have a 6 month review clock as compared to a 10 month standard review. Upon approval, this product candidate could become the first approved pharmaceutical product in the United States specifically indicated for the treatment of menorrhagia.

About Menorrhagia

HMB, or menorrhagia, represents a frequent and significant medical condition encountered by obstetricians, gynecologists and primary care physicians. Menorrhagia has been described as regular, normal intervals of menstruation with excessive volume that may exceed 80 milliliters of blood loss per menstrual cycle. At present, no pharmacotherapy has ever been approved by the FDA for the treatment of this disorder.

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 revenue generating products consisting of 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. Upcoming Symposium to Bridge the Gap between Osteoporosis Research and its Applications to Clinical Practice with Focus on Secondary Osteoporosis, Osteoporosis in Men, and Lessons from Space Travel for Improving Bone Health
2. Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
3. GlobalMedia Provides Free Grant Writing and Application Assistance to Healthcare Providers and Professionals Seeking Their Share of Billions in Economic Stimulus Dollars
4. CareTech Solutions Launches Robust Service Desk Solution to Support Clinical Applications and Technology within Continuum Health Partners Hospitals
5. Hollow gold nanospheres show promise for biomedical and other applications
6. Call for Presentations: Applications of High-Power Semiconductor Lasers Conference & Exhibit
7. FDA Clears Cellectars IND Application for Lead Drug Candidate
8. FDA Halts New Applications From Indian Drug Makers Plant
9. CUREXO Technology Corporation Announces 510(k) Submission to FDA for Total Knee Arthroplasty Application
10. Nephros Provides Update on 510k Applications
11. IMRIS announces development program for MR guided radiation and interventional applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
(Date:5/26/2016)... Washington, D.C. (PRWEB) , ... May 26, 2016 , ... ... the men and women who lost their lives in military battle for the country. ... discount cards in 2015 to provide more programs that empower independence for disabled military ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people ... cancer survivors worldwide. On Sunday, June 5, 2016, communities around the world will gather ... Day®. , National Cancer Survivors Day® is an annual worldwide Celebration of Life ...
(Date:5/26/2016)... ... 2016 , ... Dr. James Maisel will present on “Macular ... on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public Library. The presentation ... of New York , is a Board Certified ophthalmologist who completed his fellowship ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... SAN FRANCISCO , May 27, 2016 ... biotechnology company focused on developing products for Regenerative Medicine, Neurology and ... Commissiong will be presenting at two upcoming investor conferences: ... Conference Center, 730 Third Avenue, New York City ... at 3:00pm Marcum MicroCap Conference   ...
(Date:5/26/2016)... May 26, 2016   Change Healthcare ... analytics, network solutions and technology-enabled services designed ... entered into a strategic channel partnership with ... software solutions and revenue cycle management services ... and rehabilitation clinics to optimize revenue, operational ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May 25, 2016 ... ; Frankfurt Prime Standard: QIA) today announced that the company ... Diagnostics GmbH to develop and commercialize predictive assays in oncology. ... as a marker to predict effectiveness of anthracycline treatment in ... "We are pleased to partner with Therawis, which developed the ...
Breaking Medicine Technology: