Navigation Links
ADVENTRX Submits Exelbine™ New Drug Application
Date:11/3/2010

SAN DIEGO, Nov. 3, 2010 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine.

"Our Exelbine submission includes twelve months of site-specific stability data from our intended commercial manufacturer, which fulfills a request communicated to us by the FDA earlier this year.  We believe this submission will be accepted for review in early 2011 and we look forward to working with the Agency toward our first product approval," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

ADVENTRX retains exclusive worldwide rights to Exelbine, other than in China, Hong Kong, Macau and Taiwan.  In March 2010, the FDA conditionally accepted "Exelbine" as the proposed proprietary name for ANX-530.  In October 2010, patent claims related to Exelbine were allowed by the United States Patent and Trademark Office.  These patent claims, when issued, will extend into 2024.  

ADVENTRX is seeking approval of Exelbine for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer.  ADVENTRX submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug.  The Company's 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug.  In this clinical bioequivalence study, Exelbine and the reference drug were determined by ADVENTRX to be bioequivalent.  

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are bein
'/>"/>

SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
2. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
3. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
4. ADVENTRX Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CoFactor(R) for the Treatment of Advanced Breast Cancer
5. ADVENTRX to Present ANX-201 Preclinical Data at Keystone Symposia HIV Pathogenesis Conference
6. ADVENTRX to Present CoFactor Phase 2 Breast Cancer Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
7. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
8. ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
9. ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
10. ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)
11. ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... SAN DIEGO , Oct. 1, 2014  ResMed (NYSE: ... people sleep and the first company to design complete sleep ... to educate women about the importance of a good night,s ... initiative will challenge the myth that feeling tired is just ... to understand that sleep is a critical pillar of health, ...
(Date:10/1/2014)... and NEW YORK , October 1, ... Research Organization (CRO) and service provider for the medical industries, announced ... of offices in New York City . genae ... City is strategically centered in one of the highest ... Coast", said Philippe Kassab , President at genae Americas. "The ...
(Date:10/1/2014)... 1, 2014 NeuroCall, Inc., ("NeuroCall") announced today ... Telestroke and Teleneurology services. Dr. Ricardo Garcia-Rivera , ... are extremely proud that our quality of service has ... to provide lifesaving support and continuity of care to ... the United States ." ...
Breaking Medicine Technology:ResMed Launches Initiative to Help Women Get Better Sleep 2ResMed Launches Initiative to Help Women Get Better Sleep 3genae Opens Offices in New York City 2NeuroCall Awarded Joint Commission Accreditation 2
... Despite difficult economic conditions, Allied Healthcare Products (Nasdaq: ... in the first quarter of fiscal year 2011. Sales increased ... for the first quarter of fiscal 2010. An ... carbon dioxide absorbent products used in anesthesia procedures narrowly tipped ...
... Systems Ltd. (Nasdaq: DHRM ) ("Dehaier" or ... marketing and sale of medical devices and homecare medical ... a $2 million medical device distribution bid for a ... Bank Corp ("CDB"). CDB is a ...
Cached Medicine Technology:Allied Healthcare Products Reports Narrow Loss for Quarter But Improves Year-Over-Year Performance 2Allied Healthcare Products Reports Narrow Loss for Quarter But Improves Year-Over-Year Performance 3Allied Healthcare Products Reports Narrow Loss for Quarter But Improves Year-Over-Year Performance 4Dehaier Medical Wins $2 Million Distribution Bid for Rural Healthcare Construction Project 2Dehaier Medical Wins $2 Million Distribution Bid for Rural Healthcare Construction Project 3
(Date:10/1/2014)... Inc., announced today their new NoteSwift™ 2.0 for Allscripts ... the bridge between the EHR and Dragon Medical interpreting ... at the point of care. NoteSwift reduces the time ... than half – and virtually eliminates mouse clicks – ... EHR use according to the June 12, 2014 HIMSS ...
(Date:10/1/2014)... Dar, Ethiopia, at the occasion of the Leishmaniasis ... 150 African and international leishmaniasis experts, results of ... efficacy monitoring plan, carried out by MSF, ... and Ethiopia, were presented to key decision makers ... of kala-azar with the combination of Sodium Stibogluconate ...
(Date:10/1/2014)... Dr. Saj Jivraj, one of the world’s ... to Chennai, India, tomorrow to speak at the Indian ... , Dr. Jivraj is founder of the Anacapa Dental ... one of the world’s foremost prosthodontists, meaning he is ... speaking to the Indian Society of Oral Implantologists about ...
(Date:10/1/2014)... After undergoing a trial-and-error process in ... to join, Living Well Assisted Living at Home recently ... County, the home of its headquarters. , Although Living ... the thought of adding one more activity to their ... for the right chamber to join because membership in ...
(Date:10/1/2014)... CA (PRWEB) October 01, 2014 After ... documentary film, "Beautiful Births", emerging filmmaker Jacqui Blue is ... other women discover the truth about natural birth. The ... people all over the world and has been an ... Many of the topics highlighted in the film provide ...
Breaking Medicine News(10 mins):Health News:NoteSwift Joins Allscripts Developer Program 2Health News:NoteSwift Joins Allscripts Developer Program 3Health News:Results of large-scale roll out of combination treatment for kala-azar in Eastern Africa 2Health News:One of Woodland Hills’ Top Cosmetic Dentists Speaking to Indian Society of Oral Implantologists Tomorrow 2Health News:One of Woodland Hills’ Top Cosmetic Dentists Speaking to Indian Society of Oral Implantologists Tomorrow 3Health News:One of Woodland Hills’ Top Cosmetic Dentists Speaking to Indian Society of Oral Implantologists Tomorrow 4Health News:One of Woodland Hills’ Top Cosmetic Dentists Speaking to Indian Society of Oral Implantologists Tomorrow 5Health News:Living Well Joins San Rafael Chamber of Commerce 2Health News:Living Well Joins San Rafael Chamber of Commerce 3Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 2Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 3Health News:Filmmaker Jacqui Blue's Beautiful Births Documentary, "Really Touched My Heart" 4
... Minnesota has received three awards for excellence from the Disease Management Purchasing ... awards are in recognition of Blue Cross, performance in achieving cost savings ... efforts improved quality of care in: , , ... asthma , ...
... Mich., Feb. 9 my1HIE and ... association with the my1HIE(SM) health information exchange. ... and participate in myWorkspace(SM), the physician web portal, ... by physicians for physicians and under development with ...
... Throughout February, Kaz, Inc., the makers of ... annual "National Care About Your Indoor Air" month. ... the National Parent Teacher Organization and the Healthy ... Products is working to educate consumers about the ...
... Feb. 9 VNUS(R) Medical,Technologies, Inc. (Nasdaq: ... minimally invasive treatment of venous reflux disease, today announced ... Growth Stock Conference, to be,held February 16 - 18, ... management speaker will be Peter Osborne, Chief Financial Officer ...
... resonance, or SSNMR, is a valuable tool to ... and other biomolecules. But the imaging process is ... sample for study. , Yoshitaka Ishii, associate professor ... Chicago, believes he has found a quicker and ...
... to the beach, boosts well-being, study suggests, , , MONDAY, ... that money can,t buy happiness, purchasing life experiences instead ... suggests. , In a study that asked more than ... intended to make them happy, researchers found that people ...
Cached Medicine News:Health News:Blue Cross Receives Disease Management Awards 2Health News:Blue Cross Receives Disease Management Awards 3Health News:Huron Valley Physicians Association to Participate with my1HIE 2Health News:Huron Valley Physicians Association to Participate with my1HIE 3Health News:Honeywell Home Comfort Products' Second Annual 'National Care About Your Indoor Air' Month 2Health News:Honeywell Home Comfort Products' Second Annual 'National Care About Your Indoor Air' Month 3Health News:New technique boosts protein NMR imaging speeds 2Health News:Experiences Bring More Joy Than Possessions Do 2Health News:Experiences Bring More Joy Than Possessions Do 3
... IntraLase FS laser introduces new high precision ... now have the opportunity to offer their ... a microkeratome for creating the corneal flap. ... laser and proprietary IntraLASIK software, surgeons may ...
... Teco Diagnostics manufactures fine urine chemistry ... urine chemistry reagent strips from start ... offer more economical prices compared to ... quality. Teco Diagnostics urine reagent strips ...
... with diabetes continue to have a tremendous ... life of patients, in addition to the ... to be associated with elevated levels of ... of haemoglobin A1c (HbA1c) in a diabetic ...
The Lifestream Plus Cholesterol Monitor provides you with a comprehensive tool to help you monitor your cholesterol as part of your wellness program....
Medicine Products: