Navigation Links
Delcath Submits New Drug Application For Proprietary Chemosaturation System To The U.S. Food And Drug Administration
Date:8/15/2012

NEW YORK, Aug. 15, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for the Company's proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The Company included its Generation 2 filter in its NDA submission as a technical change to the Chemistry, Manufacturing, and Control (CMC) module.

"Our team has achieved a significant milestone with the filing of our NDA," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "We believe that our chemosaturation system provides the opportunity to satisfy a high unmet medical need to treat patients with unresectable metastatic melanoma in the liver. We also believe including our Generation 2 filter in the CMC module represents the fastest regulatory review path for the Generation 2 system, and that it is in the best interest of U.S. patients that we accelerate the potential availability of Generation 2."

"We have requested priority review of our NDA by the FDA. Assuming the NDA is accepted and that priority review is granted, our expected Prescription Drug User Fee Act (PDUFA) date would be in February of next year.  Based upon the strength of our Phase 1, 2 and 3 data, along with the limited treatment options available for patients with unresectable melanoma metastases in the liver, we believe that our application meets the FDA's criteria for priority review."

In Delcath's Phase 3 clinical trial (April 2010 data cutoff), comparing treatment with the Company's proprietary chemosaturation system to best alternative care (BAC) revealed that patients treated with chemosaturation therapy experienced a statistically significant extension in median hepatic progression free survival (hPFS) o
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Delcath Systems, Inc. Secures $20 Million Credit Facility
2. Delcath Highlights First Quarter 2012 And Recent Accomplishments
3. Delcath to Webcast Managements Presentation at Annual Meeting of Stockholders
4. Delcath Prices $20 Million Public Offering of Common Stock and Warrants
5. Delcath To Offer Second Generation Hemofiltration Cartridge In U.S. Expanded Access Program
6. Delcath Announced Changes To Board Of Directors
7. Delcath To Present At JMP Securities Healthcare Conference On July 12
8. Delcath To Conduct Second Quarter 2012 Results Conference Call
9. Delcath Reports Second Quarter 2012 Financial Results And Highlights Recent Accomplishments
10. Delcath To Present At Upcoming Investor Conferences
11. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... , July 31, 2015 The ... press release on July 28, 2015, "Surviving Your ... Launches Fundraising for Patient Safety." A ... sentence should read: "PPAHS is a ... Patients on Opioids. For more information on the National ...
(Date:7/31/2015)... 31, 2015 According to a new ... Heat, Dry Heat, Ethylene Oxide, Filtration, E-beam, Gamma), Services (Onsite ... Pharmaceuticals) - Global Forecast to 2020", published by MarketsandMarkets, The ... Billion by 2020, at a CAGR of 7.6%.from 2015 to ... market data T ables and 37 ...
(Date:7/31/2015)... Quietly, sedately, Morocco,s pharmaceutical sector is shining. ... is strong, with a well-developed base of local producers ... One place where the quality of Moroccan pharma ... quietly become the second largest African exporter of drugs ... Moroccan pharma companies have been making inroads as exporters ...
Breaking Medicine Technology:Sterilization Equipment Market is Expected to Reach USD 6.1 Billion by 2020 2Sterilization Equipment Market is Expected to Reach USD 6.1 Billion by 2020 3Sterilization Equipment Market is Expected to Reach USD 6.1 Billion by 2020 4PharmaBoardroom Releases New Morocco Pharmaceuticals Report 2PharmaBoardroom Releases New Morocco Pharmaceuticals Report 3
... 2 Dicom Solutions Inc., a leading distributor and systems ... magazine,s latest list of the country,s fastest-growing private businesses. The ... 500 list, achieving a three-year sales growth of 1,473.9 percent. ... be recognized for our growth in the medical imaging solutions ...
... AURORA, Ohio, Nov. 2 PartsSource, the nation,s leading ... has won its third Cascade Capital Award, this time ... had previously won Cascade Capital Awards for Technology development ... given annually to Northeast Ohio companies providing excellence in ...
Cached Medicine Technology:Medical Imaging Solutions Firm Dicom Solutions Ranks No. 109 on the Inc. 500 2
(Date:8/1/2015)... ... ... Calvary Hospital today announced that it is embarking on a yearlong restoration ... bring this Torah – dating from 1880 – back to kosher status, so that ... Scroll No. 515, from the town of Taus-Domazlice, is on permanent loan to Calvary ...
(Date:8/1/2015)... ... August 01, 2015 , ... Brig and Lita Hart, icons of the network ... their Healthy Home mission with the HOPE Movement of EvolvHealth. In what has been ... companies have agreed to join their missions of purpose together to change the course ...
(Date:8/1/2015)... ... August 01, 2015 , ... On Tuesday, July 28th, ... who are thought to have been behind the attack on Anthem Inc. which resulted ... zero day exploits, watering hole attacks and spear phishing campaigns. , For ...
(Date:8/1/2015)... ... 01, 2015 , ... BeverlyD, owner and founder of BeverlyD Luxe Organic Hair ... first small business donation to kick off the campaign for healing and Well-Being. , ... includes a complete line of raw, organic hair care products, as well as her ...
(Date:8/1/2015)... ... ... On March 19, 2015 Phil Valentine – the Executive Director of Connecticut Community for Addiction ... stepping off Springer Mountain and heading north. Since that day, Phil has hiked over 1400 ... greeted by friends and family. He visited CCAR and left an inspirational message to ...
Breaking Medicine News(10 mins):Health News:Calvary Hospital Announces Plans to Restore Historic Torah 2Health News:Calvary Hospital Announces Plans to Restore Historic Torah 3Health News:Looking for HOPE? Healthy Home Has Evolv’d 2Health News:Looking for HOPE? Healthy Home Has Evolv’d 3Health News:Frenemy at the Gates - Hackers Excel at Leveraging Trust 2Health News:Frenemy at the Gates - Hackers Excel at Leveraging Trust 3Health News:Frenemy at the Gates - Hackers Excel at Leveraging Trust 4Health News:March4thforWellBeing Foundation Kickoff 2Health News:Connecticut Executive Hikes Appalachian Trail to Raise Awareness About Recovery. 2
... week's BMJ have their say on whether patients should have ... ,The medical profession is concerned that, in the proposed ... input from the patient, and this is not being made ... Alan Hassey in a letter to this week's journal. ...
... Remedies Ltd today said it has filed its ... fixed dose combination used in the treatment of ... combination, active against multi-resistant strains of both gram- ... coverage of bactericidal activity, it informed the Bombay ...
... journal Substance Abuse Treatment, Prevention and policy unwinds that the ... alcohol dependent patients better for a long term. ... who abstain from drinking alcohol is more than the patients ... at the medical school. Also the abstinence is longer ...
... investigation has revealed that some homeopathic clinics advice people ... of the world.// ,People planning on taking ... avoid homeopathic remedies that are claiming to prevent malaria, ... ,It was reported that every year almost around ...
... Essar group and the Jindal group have committed to ... medicare for people leaving Below Poverty Line in Jharkhand. ... the Sarva Swasthya Mission trust is being formed by ... an official release said here today Independently run by ...
... selected Indian ministry of health and family welfare for ... stance on health promotion and tobacco control"//. ,Minister ... the award at a ceremony during the World Conference ... said. ,The award has been conferred on ...
Cached Medicine News:Health News:Electronic Patient Record "Serious Threat" to Patient Confidentiality 2Health News:Travellers Cautioned Over The Alternate Remedies For Malaria 2
A modular concept consisting of two J-Arms, to be fixed at any position of the skull clamp, allowing to the surgeon an unobstructed access to the surgical field....
Spoon end periosteal, polished finish, designed for large mucoperiosteal flaps....
Iowa University periosteal elevator, blade width 11/16" (17 mm), length 7 1/4" (184 mm)....
Cushing Little Joker periosteal elevators, solid handle, blade width 1/4" (6 mm), length 7 1/2" (191 mm)....
Medicine Products: