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:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
Breaking Medicine Technology: