Navigation Links
Delcath Systems Receives Refusal to File Letter From FDA
Date:2/22/2011

NEW YORK, Feb. 22, 2011 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) announced today that the Company has received a "refusal to file" letter from the U.S. Food & Drug Administration (FDA) for the New Drug Application (NDA) for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride.  Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted.  Based on management's current understanding of the information in the FDA's letter, the Company intends to resubmit the NDA by September 30, 2011.  

In accordance with application regulations, the FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on December 22, 2010.  Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of the chemosaturation system.

"The FDA's letter requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information that we already planned on filing with our 120 day safety update in April, as well as additional statistical analysis clarification," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "We believe that we will be able to provide the requested information in an updated application and we expect to resubmit the NDA by the end of the third quarter of this year.  In the meantime, the CE Mark Technical File review process for marketing approval of the Hepatic ChemoSAT™ Delivery System continues on schedule.  Our expec
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Delcath Achieves ISO 13485 Certification
2. Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
3. Delcath Systems Announces Third Quarter Progress Report Conference Call
4. Delcath Strengthens Research and Development Team with Key Appointments
5. Delcath Signs Agreement With Synerx and Mylans Bioniche Teoranta for Melphalan Supply
6. Delcath to Present at the William Blair Emerging Growth Stock Conference
7. Delcath to Present at the JMP Securities Healthcare Conference
8. Delcath Systems Announces Completion of Common Stock Offering
9. Delcath to Present at the 30th Annual Canaccord Global Growth Conference
10. Delcath to Present at the 2010 Wedbush Securities Life Sciences Best Ideas Management Access Conference
11. Delcath Systems Announces Second Quarter Progress Report Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... and NEW YORK , Aug. 1, ... Pershing Square Capital Management, L.P. today responded to the ... AGN ) in California.  The complaint makes ... tender offer rules.  Allergan,s true purpose ... with shareholders, efforts to call a special meeting.  That ...
(Date:8/1/2014)... 1, 2014  VanDeMark Chemical Inc., ... of phosgene and phosgene derivatives in ... has acquired Framochem Kft, a leading European-based manufacturer ... . The purchase unites two ... of the world,s largest, independent manufacturers of products ...
(Date:8/1/2014)... Aspire Technology Partners (Aspire) announced today that it has achieved ... recognizes Aspire for delivering outstanding customer service to customers in ... "Achieving exceptional results for our customers is core to ... CEO of Aspire. "We are pleased Cisco has recognized our ... are proud to be part of the Cisco channel." ...
Breaking Medicine Technology:Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 2Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 3Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 4Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 5Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 6VanDeMark Chemical Inc. Acquires Framochem 2VanDeMark Chemical Inc. Acquires Framochem 3VanDeMark Chemical Inc. Acquires Framochem 4Aspire Technology Partners Recognized By Cisco For Excellence In Customer Satisfaction 2
(Date:8/1/2014)... Summer is here, and with it comes the ... and they can be a pain for dogs. Animal Emergency ... their customers get rid of ticks and prevent them completely. ... the summer, which is why they are so active during ... woodland areas and carry a number of diseases, including lyme ...
(Date:8/1/2014)... The American Telemedicine Association (ATA) ... and Peter Welch (D-VT), for their latest actions ... Act of 2014, which improves telemedicine coverage in ... improve healthcare access and affordability using telecommunications technology," ... "These cost-saving provisions are critical to improve telehealth ...
(Date:8/1/2014)... 01, 2014 The "Antimicrobial Coatings ... as Zinc Oxide, Titanium Dioxide, and Zinc Omadine), ... Construction, Food & Beverages, Textiles, and others), & ... Global Trends and Forecasts to 2018" analyzes the ... opportunities, and trends in the diverse geographical regions. ...
(Date:8/1/2014)... 2014 The North America Endpoint Security ... market in North America with analysis and forecast of ... $3.53 billion in 2014 to $4.77 billion by 2019, ... , Browse through the TOC of the North America ... the in-depth analysis provided. It also provides a glimpse ...
(Date:8/1/2014)... NY (PRWEB) August 01, 2014 ... Generators Market Outlook to 2020", provides key ... Generators market. The report provides value, in ... and average prices (in US dollars) within ... Generators, Ultrasonic Generators and Argon Plasma Coagulation ...
Breaking Medicine News(10 mins):Health News:Tis the Season for Tick Prevention 2Health News:ATA Applauds Bill on Medicare Telemedicine Improvements 2Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 2Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 3Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 4Health News:North America End-Point Security Market is Expected to Reach $4 billion in 2019 - New Report by MicroMarket Monitor 2Health News:North America End-Point Security Market is Expected to Reach $4 billion in 2019 - New Report by MicroMarket Monitor 3Health News:North America End-Point Security Market is Expected to Reach $4 billion in 2019 - New Report by MicroMarket Monitor 4Health News:United Kingdom Surgical Generators Market Size, Share, Analysis, Trends and Forecasts 2020 2Health News:United Kingdom Surgical Generators Market Size, Share, Analysis, Trends and Forecasts 2020 3
... Julian, had a brain tumor the size of a golf ball. A ... diagnosed with the same rare form of cancer, called medulloblastoma. Before that, ... III Rhabdomyosarcoma, a very aggressive soft muscle tumor. , ... CHICAGO ...
... Nov. 6 /Xinhua-PRNewswire-FirstCall/ -- Tianyin,Pharmaceutical, Co., Inc., (Amex: ... traditional Chinese medicine ("TCM") based in Chengdu, China,today ... to discuss its,2009 fiscal first quarter at 8:30 ... will be released that day before the market ...
... N.J., Nov. 6 At RSNA 2008 ... MEDQ ) is introducing a,powerful integration ... speech recognition application, and RadWorkFlow(R), a,robust workflow ... offers an efficient, simplified, and consolidated view ...
... 6 Continuing its efforts to,educate, inform, and ... a,not-for-profit patient-focused organization, is hosting its 25-minute live,call-in ... on,Monday, November 10, 2008 at 6:00 PM on ... frank discussion with Joy Loverde, a,nationally known expert ...
... 6 Arizona-based Cain and Associates (C&A),( ... alliance with JDA eHealth Systems, Inc. of ... eHealth Systems will now be able to ... and GRIP (Government,Revenue Integrity Program) products to ...
... and CARLSBAD, Calif., Nov. 6, Isis Pharmaceuticals, Inc. (Nasdaq: ISIS ),announces the following webcast:, ... late-stage research candidates, including presentations ... -- Dr. Erik Stroes reporting top line data from an ongoing ... liver imaging study -- Dr. ...
Cached Medicine News:Health News: Three Women in Health Crises Go Online to Form Lifelong Friendships : Mothers of Boys with Cancer Find Support, Encouragement and Each Other at CarePages.com 2Health News: Three Women in Health Crises Go Online to Form Lifelong Friendships : Mothers of Boys with Cancer Find Support, Encouragement and Each Other at CarePages.com 3Health News:Tianyin Pharmaceutical Co., Inc. to Host Fiscal Year 2009 First Quarter Earnings Conference Call on Tuesday, November 11, 2008 at 8:30 a.m. EST 2Health News:MedQuist Introduces SpeechQ for Radiology Integrated with RadWorkFlow 2Health News:MedQuist Introduces SpeechQ for Radiology Integrated with RadWorkFlow 3Health News:Health Caring for the Elderly 2Health News:Cain & Associates Forms Strategic Partnership With JDA eHealth Systems, Inc. 2Health News:Webcast Alert: Isis Pharmaceuticals' Cardiovascular Program Review 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: