Navigation Links
Deston Therapeutics Stands By Safety and Efficacy of Auralgan After FDA Action
Date:2/25/2011

the evidence presented in its Citizen Petition, provide a thorough explanation for the reasons that it believes the combination is not GRAS/E, the matter is now up to a court to make a final legal decision on the new drug status of the articles that have been seized.  Until the court rules on the old drug- new drug issue for the seized goods,  the matter has not been legally resolved Mr. Allera noted.  

"We continue to believe, as we always have, that Auralgan is a safe and effective treatment for ear pain and inflammation," said Mr. Preston.  "Deston looks forward to working with the government to resolve all outstanding issues related to the regulatory classification of this drug product."

According to the original complaint, Deston has thirty-five days to claim the seized Auralgan, and after claiming the seized goods, Deston has 20 days to file an answer to the complaint.  Mr. Preston said that Deston is currently exploring its legal options regarding how best to respond to this seizure.


'/>"/>
SOURCE Deston Therapeutics LLC
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
3. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
4. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
5. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
6. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
7. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
10. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
11. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Sept. 19, 2014  Pressure BioSciences, Inc. (OTCQB: ... has received and approved all parts required to ... has begun to manufacture the new PCT-based instrument ... be ready for shipment by mid-October and that ... at a rate of about one per week ...
(Date:9/19/2014)... 19, 2014 Aufgrund der ... äußerst erfolgreichen Serialisierungs-Countdown-Kalender aktualisiert, der jetzt auch die ... verfügbar unter pharmaserialisation.com , zeigt die Serialisierungsanforderungen ... in Kraft treten. Für international tätige ... um das "ob", sondern darum, "wann" sie die ...
(Date:9/19/2014)... and CAMBRIDGE, Mass. ... Inc. (PGDx), a provider of advanced cancer ... Medicines , a leader in discovering and developing ... today disclosed the first-ever comprehensive genomic study of ... deadly cancer of the female reproductive system, also ...
Breaking Medicine Technology:Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 2Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 3Pharma IQ stellt weltweite Serialisierungsfristen in seinen Countdown-Kalender 2014 - 2018 2First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 2First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 3First Discovery Of Actionable Genetic Alterations In A Deadly Cancer Reported By Personal Genome Diagnostics And Blueprint Medicines 4
... , , , ... HBP; OTCQX: HXBPF) today announced financial results for the first ... HIGHLIGHTS , DOS47/L-DOS47 , Helix announced that a ... Food and Drug Administration ("FDA") in which the FDA generally ...
... ... new market research report is available in its catalogue: , ... , http://www.reportlinker.com/p0164322/Medical-Fiber-Optics---A-World-Market-Analysis.html , Fiber optics work on ... enclosed in an element encased by glass in air of ...
Cached Medicine Technology:Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 2Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 3Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 4Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 5Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 6Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 7Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 8Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 9Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 10Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 11Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 12Helix BioPharma Corp. Announces Fiscal Q1 2010 Results 13Reportlinker Adds Medical Fiber Optics - A World Market Analysis 2Reportlinker Adds Medical Fiber Optics - A World Market Analysis 3Reportlinker Adds Medical Fiber Optics - A World Market Analysis 4Reportlinker Adds Medical Fiber Optics - A World Market Analysis 5Reportlinker Adds Medical Fiber Optics - A World Market Analysis 6
(Date:9/20/2014)... Everett, WA (PRWEB) September 20, 2014 “Motherhood ... Health Center of Snohomish in their latest article , ... the best that you can—and that’s what we want to ... what services they need and should expect from their Family ... the following days of new motherhood. , To learn ...
(Date:9/19/2014)... Nearly 780 Risperdal lawsuits are moving forward in ... took place to discuss the next steps in ... mass tort program. Attorneys for the plaintiffs and defendants ... Complex Litigation Center in Philadelphia’s City Hall where the ... lawsuits filed against Johnson & Johnson and its subsidiary, ...
(Date:9/19/2014)... 19, 2014 Are you tired of ... problems with seasonal allergies or sinus congestion? Fortunately, an ... alternative. , She conceived of Nose Pal to ... runny nose in public. Since it prevents nasal drip ... sanitary conditions, particularly when cooking or working closely with ...
(Date:9/19/2014)... 19, 2014 (HealthDay News) -- As kids transition from ... of cyberbullies, according to a recent study. ... through 8 found that verbal and physical bullying declines ... bullying intervention and prevention strategies must address all types ... boys and girls, the researchers said. The study was ...
(Date:9/19/2014)... 19, 2014 Hastings and Hastings, a discount ... the industry, announces a record number of visitors to its ... variety of serious injury cases as well as auto accident ... bite related accident cases and others. Having served the state ... stood the test of time when it comes to dedicated ...
Breaking Medicine News(10 mins):Health News:Newest Article from Community Health Center of Snohomish County Highlights The Importance of Proper Health Care for Expectant Mothers 2Health News:Risperdal Lawsuits Move Forward As Attorneys Meet To Discuss Litigation, Reports Wright & Schulte LLC 2Health News:Risperdal Lawsuits Move Forward As Attorneys Meet To Discuss Litigation, Reports Wright & Schulte LLC 3Health News:Risperdal Lawsuits Move Forward As Attorneys Meet To Discuss Litigation, Reports Wright & Schulte LLC 4Health News:Nasal Drip Eliminator Invented by InventHelp Client (LCC-218) 2Health News: Cyberbullying Seems to Ramp Up in Middle School 2Health News:Hastings And Hastings Announces a Record Number of Visitors to Its New Phoenix Personal Injury Website 2
... help those who have it, to live really long.// Strangely ... mental faculties also. This new research work was presented by ... University. December 26, 2006 issue of Neurology published their findings. ... of the Institute for Aging Research at Einstein. He along ...
... surgery years ago underwent the same procedure that he ... raring to get back to work after recuperating from the ... called aorta, in his heart ,that was torn. ,DeBakey ... for a condition called dissecting aortic aneurysm.As a young doctor ...
... Xylitol is a mint flavored sweetener, produced naturally by plants ... as an ingredient in chewing gum, toothpaste, mouthwash and other ... Research Service (ARS) and collaborators have developed a genetically engineered ... be used to produce Xylitol on a large scale. ...
... Salmonella enteriditis (SE) is present in eggs sometimes, and when ... eaten, may cause illness. The FDA (The U. S. Food ... bacteria and follow food safety practices to avoid egg-related illness. ... homemade eggnog, and some types of stuffing, contain eggs that ...
... from human kidney stones in cell cultures//and have isolated ... with nanoparticles. ,The findings, which appear in ... are significant because it is one step closer in ... forms that can lead to disease -- in this ...
... An Italian, Mario Scaramella who met - ex-KGB agent - ... radiation poisoning was arrested.// ,He was arrested on ... Rome, the man's father, Amedeo Scaramella said. ,Scaramella, ... to be arrested, met Litvinenko at a London sushi bar ...
Cached Medicine News:Health News:You may Live Long and Think Clear With a Variant Gene 2Health News:Pioneer Heart Surgeon Faced the Scalpel at 98 2Health News:Xylitol To Be Produced By Genetically Engineered E. Coli 2Health News:Link Between Nanoparticles and Kidney Stones 2Health News:Link Between Nanoparticles and Kidney Stones 3
... 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 extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: