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

nally, numerous health organizations and institutions have stated that Auralgan is safe and effective.  The United States National Library of Medicine's Medline Plus and the National Institute of Health's National Center for Biotechnology Information have stated on their webpages that Auralgan is a safe and effective treatment for ear pain and inflammation associated with AOM.  The American Academy of Pediatric and American Academy of Family Physicians along with the Institute for Clinical Systems Improvement published guidances recognizing Auralgan as a safe and effective treatment for ear pain in pediatric patients with AOM.

According to Mr. Preston, when Deston acquired Auralgan, it believed that this product qualified as an "old drug" because of the long marketing of Auralgan, the evidence supporting its safe and effective use, and the fact that the Federal Government has never concluded that it was a "new drug" or took action against the previous manufacturer of Auralgan.  

Deston was unaware that FDA believed that Auralgan was a "new drug" until the FDA informed Deston of this position last year.  In response to this information, Deston's legal counsel prepared and filed, on May 28, 2010, a "Citizen Petition" with the FDA, to make the case, point by point, why Auralgan was not a 'new drug'. Deston had expected a due process period whereby FDA would provide an in-kind formal response, explaining why they believed it was a 'new drug'.

Deston also began discussions with FDA regarding how to obtain FDA approval for Auralgan if, after addressing the Citizen Petition, the FDA decided the product qualified as a "new drug."  On February 15, 2011 – a day after the Federal Government seized Auralgan – Deston received a partial response to its Citizen Petition implying that the FDA has not yet made a determination on whether Auralgan qualifies as a "new drug" or an "old drug."  Because FDA has yet to review
'/>"/>

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:7/31/2015)... BOSTON , July 31, 2015  Boston ... children benefiting from 3D printing of their anatomy ... had life-threatening cerebrovascular malformations (abnormalities in the brain,s ... Reporting online today in the Journal ... use of 3D printing and synthetic resins to ...
(Date:7/31/2015)... July 31, 2015 Egalet Corporation (Nasdaq: ... pharmaceutical company focused on developing, manufacturing and marketing ... its previously announced underwritten public offering of 7,666,667 ... offering price of $11.25 per share. The shares ... shares issued upon the exercise in full by ...
(Date:7/31/2015)... , July 31, 2015 According ... Market by Product (Bioimpedance Analyzers (BIA), Dual-Energy X-ray Absorptiometry ... Weighing) - Global Analysis & Forecast to 2019", published ... pegged at $911.1 Million 2014 and is estimated to ... CAGR of 9.4% from 2014 to 2019. ...
Breaking Medicine Technology:3D Printing Helps Doctors Rehearse Complex Brain Procedures 23D Printing Helps Doctors Rehearse Complex Brain Procedures 33D Printing Helps Doctors Rehearse Complex Brain Procedures 4Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 2Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 3Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 4Body Composition Analyzers Market Worth $1,425.7 Million by 2019 2Body Composition Analyzers Market Worth $1,425.7 Million by 2019 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 4
... MELVILLE, N.Y., Dec. 10, 2010 For the 12th ... ), the largest provider of health care products and ... more than 1,000 children and their families through the ... Henry Schein,s Holiday Cheer program is a flagship initiative ...
... WASHINGTON, Dec. 10, 2010  The Office of Inspector General ... OIG) announced today that Miami resident Yader A. Padilla, 59, ... 2010, by the Honorable U.S. District Judge Paul C. Huck ...  He was sentenced for his role in defrauding the Ex-Im ...
Cached Medicine Technology:Henry Schein's 12th Annual Holiday Cheer For Children Program Encourages Volunteerism and Giving Among Team Schein Members 2Distributed by the Export-Import Bank of the United States On Behalf of the Independent Office of Inspector General 2
(Date:7/31/2015)... Las Vegas, NV (PRWEB) , ... July 31, 2015 , ... Ticket Down is a ... Las Vegas at the MGM Grand Garden Arena. Fans of every genre of music ... On Friday, September 18th, the first day of the festival, the following artists will perform: ...
(Date:7/31/2015)... ... ... Ticket Down is a reliable source for authentic tickets for the 2015 ... The festival will end on Sunday, August 2nd. , Music fans have ... This unique and unbelievably popular festival attracts the best in entertainment from around the ...
(Date:7/31/2015)... ... July 31, 2015 , ... The 2nd annual Ride to Fight On ... on October 3, 2015. The Ride to Fight On is a cycling fundraiser that ... Healthcare, The West Clinic and The University of Tennessee Health Science Center. A health ...
(Date:7/31/2015)... ... 31, 2015 , ... Facebook, Twitter, Linkedin and blogs are ... media profiles to better connect with the public. The agency website at ... insights and opinions. The Rally Insurance Group, Inc.’s pledge to provide effortless ways ...
(Date:7/31/2015)... ... 2015 , ... According to the article published July 27 on My News LA, ... and extinguished by the city’s fire department before it caused major damage throughout the building. ... the fire, and it was a fire alarm system that tipped off fire fighters so ...
Breaking Medicine News(10 mins):Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Cheap 2015 Lollapalooza Tickets: Ticket Down Slashes Ticket Prices on Lollapalooza Tickets at Grant Park in Chicago for Saturday, August 1st and Sunday, August 2nd 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2Health News:Article on Recent Pasadena Courtroom Fire Highlights the Effectiveness of Fire Alarm Systems, Says Fire Protection Group Inc 2Health News:Article on Recent Pasadena Courtroom Fire Highlights the Effectiveness of Fire Alarm Systems, Says Fire Protection Group Inc 3
... , MONDAY, Jan. 24 (HealthDay News) -- Preparing small doses ... dangerous dosing errors for infants and small children, warns a ... potent drugs for young patients are often prepared from stock ... equipment does not permit the accurate measurement of volumes that ...
... available in French . McGill University ... $1-million grant today for landmark research into addressing parasitic ... Canada, Canada,s International Development Research Centre, The Canadian ... Gates Foundation have joined together to support this important ...
... , MONDAY, Jan. 24 (HealthDay News) -- There,s a much ... if they score just below a round number (such as 1200) ... Researchers analyzed a set of SAT scores from 1994 to ... on. This indicates that students who got those scores were more ...
... (HealthDay News) -- People involved in winter sports such as ... so they need to know about prevention and what to ... tips from the U.S. Centers for Disease Control and Prevention: ... such as helmets. , Know the symptoms and danger signs ...
... By Steven Reinberg HealthDay Reporter , FRIDAY, Jan. ... U.S. Food and Drug Administration approve a new chemical that ... may one day help doctors diagnose the neurodegenerative disease, experts ... voted 16 to 0 to recommend approval of the imaging ...
... an 8-week mindfulness meditation program appears to make measurable ... self, empathy and stress. In a study that ... Psychiatry Research: Neuroimaging, a team led by Massachusetts ... study, the first to document meditation-produced changes over time ...
Cached Medicine News:Health News:Preparing Small Doses of Medication From Syringes Called Risky 2Health News:McGill awarded $1-million grant to address debilitating parasitic diseases in the developing world 2Health News:McGill awarded $1-million grant to address debilitating parasitic diseases in the developing world 3Health News:Prepare for Concussion Risk in Winter Sports: CDC 2Health News:Alzheimer's Scan Might Help Spot Disease 2Health News:Alzheimer's Scan Might Help Spot Disease 3Health News:Mindfulness meditation training changes brain structure in 8 weeks 2Health News:Mindfulness meditation training changes brain structure in 8 weeks 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: