Navigation Links
FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:7/29/2013

WASHINGTON, July 29, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing and granted a priority review classification to Vanda's New Drug Application (NDA) for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

The FDA grants priority review status for a "drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness" over current therapies[1].  Currently, there is no approved treatment for Non-24 and tasimelteon has the potential to address this unmet medical need.

"We are extremely pleased that the FDA has granted tasimelteon priority review for the treatment of Non-24 in the totally blind," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer.  "The agency's acceptance of the NDA and decision to place tasimelteon in a category of expedited review are important milestones for Vanda as we take another step toward our goal of providing patients with a treatment for Non-24."

The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-V), to be January 31, 2014.  The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.

About Non-24-Hour Disorder
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle.  Non-24 affects a majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs almost entirely in individuals who lack the light sensitivity ne
'/>"/>

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
2. FDA Accepts Takeda and Lundbecks Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
3. FDA Accepts Novens NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
4. Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
5. Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
6. Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
7. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
8. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
9. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
10. EPGL Medical Invents Self Powered Contact Lenses for Medical and Consumer Applications
11. FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... , Dec. 22, 2014 Research and Markets ... addition of the "Investment Analysis of the ... their offering. http://photos.prnewswire.com/prnh/20130307/600769 ... the US medical device sector identifies the key ... venture capital investments, and mergers and acquisitions. ...
(Date:12/22/2014)... Cyberonics, Inc. (NASDAQ: CYBX ), a global leader ... today announced it will participate in the 33 rd ... in San Francisco . ... speak at 11:00 AM Pacific Time.  A live audio webcast ... Investor Relations link on the Cyberonics home page at ...
(Date:12/22/2014)... MARLBOROUGH, Mass , Dec. 22, 2014 /PRNewswire/ -- ... a biotechnology company focused on discovering, developing and ... using RNA-targeted technologies, today issued the following open ... Geert Cauwenbergh , Dr. Med. Sc. ... few days a number of inaccurate statements posted ...
Breaking Medicine Technology:Investment Analysis of the US Medical Device Sector 2RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6
... March 17 Alexza,Pharmaceuticals, Inc. (Nasdaq: ALXA ) ... ended December 31, 2007, and provided an update,on the ... "During 2007 and the first quarter of 2008, we ... an important transitional year for,Alexza, as we initiate the ...
... Eye via,Ophthalmic Artery, WASHINGTON, March 17 ... -- a,deadly, inherited cancer of one or both ... having their eyes surgically removed (enucleated),according to the ... Society of,Interventional Radiology,s 33rd Annual Scientific Meeting. Advanced,retinoblastoma ...
Cached Medicine Technology:Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 2Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 3Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 4Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 5Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 6Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 7Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 8Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 9Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 10Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 11Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 12Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 13Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status 14New Localized Cancer Treatment for Advanced Retinoblastoma Saves Children From Having Eyes Removed, Restores Vision in Some Cases 2New Localized Cancer Treatment for Advanced Retinoblastoma Saves Children From Having Eyes Removed, Restores Vision in Some Cases 3New Localized Cancer Treatment for Advanced Retinoblastoma Saves Children From Having Eyes Removed, Restores Vision in Some Cases 4
(Date:12/24/2014)... 24, 2014 (HealthDay News) -- Adults who experienced ... of migraine headaches, suggests a study published online ... "Childhood maltreatment can have long-lasting effects, like ... adulthood," study author Dawn Buse, director of behavioral ... City, said in a journal news release. ...
(Date:12/24/2014)... HealthDay Reporter WEDNESDAY, ... likely to start smoking or drinking with each additional ... conduct disorder, new research suggests. "Our findings ... of substance use as [these] children approach adolescence," said ... Pediatric Research Group, which is part of Cincinnati Children,s ...
(Date:12/24/2014)... Steven Reinberg HealthDay Reporter ... from the American Diabetes Association (ADA) call for giving the ... to help prevent heart disease. These new standards bring ... and American Heart Association, which also recommend giving low- or ... including people with diabetes. "We agree that the decision ...
(Date:12/24/2014)... ladies, new fashionable outfits are necessary when heading into a ... Angeldress.co.uk has chosen some of their best dresses ... by launching a promotion on its cheap clothes and fashion ... off, like a cheap suit. , “All items are in ... are among the hottest items in the global market. They ...
(Date:12/24/2014)... 2014 Dr. Svetlana Gomer, MGS Tewksbury ... nation gathered with US Marines on November 14, 2014 ... for the Toys for Tots Literacy Program. This ... new books and audio books for the Toys for ... this Christmas. It represents another major strike in the ...
Breaking Medicine News(10 mins):Health News:Abuse in Childhood Tied to Migraines in Adulthood 2Health News:ADHD May Raise Teens' Odds for Smoking, Drinking 2Health News:ADHD May Raise Teens' Odds for Smoking, Drinking 3Health News:Nearly All Diabetics Should Be on Cholesterol-Lowering Drugs: Experts 2Health News:Nearly All Diabetics Should Be on Cholesterol-Lowering Drugs: Experts 3Health News:Angeldress.co.uk Starts Its Big Sales by Offering Various Kinds of Cheap Clothes and Fashion Accessories 2Health News:Dr. Svetlana Gomer, MGS Tewksbury Dental and Other Dentists Working With the U.S. Marines Strike Again In the Battle Against Illiteracy 2Health News:Dr. Svetlana Gomer, MGS Tewksbury Dental and Other Dentists Working With the U.S. Marines Strike Again In the Battle Against Illiteracy 3
... Court on Monday upheld a ban on a teenager from wearing ... sex before marriage. ,Lydia Playfoot, 16, said she ... school, the Millais School in Horsham, West Sussex, denies infringing her ... of the Christian faith and violates its uniform policy. ...
... Illinois at Chicago have created a theoretical blueprint for ... , ,Scientists say the propeller opens the possibility ... out of cells. ,, ,Petr Krl, Assistant ... used classical molecular dynamics simulations to learn how tiny ...
... webcams and other new technological innovations have transformed the ... an international congress of the deaf said Tuesday. ... the internet, internet, webcams, email, SMS and chat ... institute for the deaf in the eastern city of ...
... the world. Perhaps one way out could be treating everyone ... , Sir Liam Donaldson, Englands Chief Medical Officer has suggested. ... leads to the deaths of hundreds of patients on waiting ... cent of people want to donate their organs after death, ...
... to a study published Neurology, the medical journal of the ... perform worse in school than healthy kids , grades in ... harder time than boys in getting good grades. ... grades and subjects of brain tumor survivors have been reported. ...
... A few months back, the Food and Drug Administration approved ... effective at preventing pregnancy as the other pills already in ... who take it will never get their periods. ... may never be the same- it may disappear altogether. ...
Cached Medicine News:Health News:New Technology Transforming Life for the Deaf 2Health News:Treat Every Patient as a Potential Organ Donor, British Health Official Says 2Health News:Brain Tumor Children Poor Performance in Schools 2Health News:The Queen Of All Contraceptives Released 2
... 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 ...
... 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 ...
... 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 ...
... 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: