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:4/27/2015)... 27, 2015 The North ... type, application, and geography and includes analysis and forecast of ... and is expected to reach $829.9 million by 2019, at ... Browse through the TOC of the North America Optical microscopy ... provided. This also provides a glimpse of the segmentation in ...
(Date:4/27/2015)... Texas , April 27, 2015 /PRNewswire/ ... company focused on gynecologic disease, announced today ... results after the market close on Monday, ... conference call and webcast at 4:30pm Eastern.Conference ... at 4:30pm Eastern/1:30pm Pacific Domestic: , 888-556-4997International: ...
(Date:4/27/2015)... , April 27, 2015  As the Innovation ... Philadelphia , InCrowd, provider of on-demand ... assembly of life science insights experts in charting a ... technology and innovation in research. Presented jointly ... supported by Communispace Health, IIeX Health features TED-style presentations ...
Breaking Medicine Technology:North America Optical Microscopy Market is Expected to Reach $829.9 Million by 2019, at a CAGR of 3.0% From 2014 to 2019 2North America Optical Microscopy Market is Expected to Reach $829.9 Million by 2019, at a CAGR of 3.0% From 2014 to 2019 3InCrowd Helps IIeX Health 2015 Chart New Paths for Turning Physician Insights Into Innovation 2InCrowd Helps IIeX Health 2015 Chart New Paths for Turning Physician Insights Into Innovation 3
... ,Rosetta Genomics Ltd. (Nasdaq: ROSG ) reported ... systemic microRNA-based cancer therapeutic. The,animal-model study demonstrated a ... be over expressed in human hepato-cellular carcinoma (HCC), ... data are being presented,at the Keystone Symposium, Therapeutic ...
... reduced the risk of cardiovascular hospitalization or death by ... 11 Sanofi-aventis (Paris Bourse: EURONEXT: SAN; ... today that the ATHENA trial was published in the ... Multaq(R) (dronedarone), in addition to standard therapy, significantly reduced ...
Cached Medicine Technology:Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer 2Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer 3Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer 4Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer 5New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation 2New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation 3New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation 4New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation 5New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation 6
(Date:4/27/2015)... NJ (PRWEB) April 27, 2015 As ... security management standard for companies of all sizes and ... leader in helping companies prepare for ISO 27001 certification. ... of clients to prepare them for ISO 27001 certification. ... ever, as evidenced by the number of Lead Implementers ...
(Date:4/27/2015)... Church, VA (PRWEB) April 27, 2015 ... Integrity Issues Within Your Operations or Your Partners/Suppliers, **FDAnews ... p.m. EDT, http://www.fdanews.com/DataIntegrity , Data integrity issues ... the last few years., Uncovering data integrity issues within ... once data integrity issues come to light, remediating them ...
(Date:4/27/2015)... 27, 2015 Cannabix Technologies Inc. (CSE: ... Mr. Rocco Iannapollo has become an Advisor to Cannabix ... law enforcement and workplace testing. Mr. Iannapollo is an ... years of experience in the oil and gas industry, ... with supplier, employer, and DOT compliance policies and strategies. ...
(Date:4/27/2015)... 27, 2015 The global coagulation ... lower CAGR in developed countries; however, it is ... such as China, India and Brazil in the ... market is driven by factors such as increasing ... development of high-throughput hemostasis analyzers, developments in high-sensitivity ...
(Date:4/27/2015)... April 27, 2015 The Global Pharmaceutical ... at a CAGR of 5.9% during the period 2015 ... in the materials healthcare packaging market, mainly due to ... Pharmaceutical Packaging market is extremely fragmented with the ... major portion of the market with the rest being ...
Breaking Medicine News(10 mins):Health News:Six Additional New ISO 27001 Lead Implementers Certified for Pivot Point Security 2Health News:FDAnews Announces — Data Integrity Problems on the Rise: Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers Webinar, May 19, 2015 2Health News:FDAnews Announces — Data Integrity Problems on the Rise: Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers Webinar, May 19, 2015 3Health News:FDAnews Announces — Data Integrity Problems on the Rise: Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers Webinar, May 19, 2015 4Health News:Rocco Iannapollo becomes an Advisor to Cannabix Technologies 2Health News:Rocco Iannapollo becomes an Advisor to Cannabix Technologies 3Health News:Rocco Iannapollo becomes an Advisor to Cannabix Technologies 4Health News:Coagulation Analyzers Market Concluded to Reach $3.58 billion by 2019 2Health News:Coagulation Analyzers Market Concluded to Reach $3.58 billion by 2019 3Health News:Global Pharmaceutical Packaging Market to Grow at 5% CAGR to 2019 Says a New Report at RnRMarketResearch.com 2Health News:Global Pharmaceutical Packaging Market to Grow at 5% CAGR to 2019 Says a New Report at RnRMarketResearch.com 3Health News:Global Pharmaceutical Packaging Market to Grow at 5% CAGR to 2019 Says a New Report at RnRMarketResearch.com 4
... to Enable an Internationally Interoperable Healthcare Identity ... ... 22 Liberty Alliance, the global,identity consortium working to build ... announced the launch of a,global public forum formed to develop ...
... fare worse; risks, health-care system cited as factors , , FRIDAY, ... prevalence of stroke than their European counterparts, possibly because of ... those in the United States, says a new study. , ... odds of having a stroke, and U.S. women had almost ...
... (ADF) are the most frequent aorto-enteric fistulae (80%) ... is upper gastrointestinal bleeding (UGI). A 59-year-old male ... ago, was admitted to the Emergency Room after ... and biliary vomiting. Computed tomography (CT) scan showed ...
... chemotherapeutical drug. It exerts its antitumor effect ... synthase (TS) catalyses deoxyuridine-5-monophosphate (dUMP) to 2-deoxythymydine-5-monophosphate ... source of thymidylate, an essential precursor of ... TS gene, there a unique tandem repeated ...
... prevalence of stroke than their European counterparts, due in part ... and barriers to care in the United States, according to ... Conference 2008. , Compared to European men, U.S. men had ... women had almost twice the odds of stroke as European ...
... emerging for heart patients, , , FRIDAY, Feb. 22 (HealthDay News) ... the artery-opening device is best? When is heart bypass surgery ... many heart patients are left asking themselves and their doctors, ... studies have compared the performance and safety of various types ...
Cached Medicine News:Health News:Global Interoperability and Patient Privacy Focus of New Liberty Alliance Health Identity Management Group 2Health News:Stroke More Prevalent in U.S. Than in Europe 2Health News:A strange case of upper obstructive syndrome 2Health News:What are simple ways to judge the efficacy of 5-fluorouracil in colonic neoplasm? 2Health News:Stroke more prevalent in United States than in Europe 2Health News:Stroke more prevalent in United States than in Europe 3Health News:Experts Offer Clarity on Confusion Surrounding Stents 2Health News:Experts Offer Clarity on Confusion Surrounding Stents 3Health News:Experts Offer Clarity on Confusion Surrounding Stents 4Health News:Experts Offer Clarity on Confusion Surrounding Stents 5
... The 5mm AEM Laparoscopic Instruments incorporate ... AEM Instruments are shielded and monitored to ... of the instrument caused by insulation failure ... risk. The protective shield built into all ...
... Wolf offers protection ... exceptional shielding values with ... high optical quality. Lenses ... equivalency and are anti-reflection ...
Wolfs unique apron and vest set distributes weight evenly between shoulders and hips. The vest comes with an attached Thyroid collar - .5mm lead equivalency protection front, 5mm back....
... Wolfs Coat Aprons feature a 2 adjustable belt ... belt helps lift the Apron off your shoulders. ... designed specifically for the female anatomy. ,For additional ... Belts - they reduce pressure on the vertebrae ...
Medicine Products: