Navigation Links
FDA Approves Viibryd to Treat Major Depressive Disorder
Date:1/21/2011

SILVER SPRING, Md., Jan. 21, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.  

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

For more information:

FDA: Antidepressant Use in Children, Adolescents, and Adults

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm096273.htm

National Institute of Mental Health: Depression

http://www.nimh.nih.gov/health/topics/depression/index.shtml

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/14/2017)... 14, 2017  ivWatch LLC, a medical device company ... (IV) therapy, is pleased to announce it was the ... Hospital Supplies and Equipment at the 2017 Medical Design ... medtech industry. The award was presented by Medical Device ... Center in New York during ...
(Date:6/14/2017)... -- In 2016, Embodied Labs took top prize ... came away with $25,000 in seed-fund investment. Embodied Labs ... "entering the life of another" and by the Journal ... medical professionals in an entirely new dimension." Building upon ... for the Department of Education,s EdSimChallenge, where they received ...
(Date:6/12/2017)... Kineta, Inc., a biotechnology company focused on the ... President of R&D and Head of Virology Kristin Bedard has ... the Northwest and Beyond meeting sponsored by Life Science ... from 8:30-10:30 AM PDT at the Agora Conference Center in ... Bedard will be joined by other leaders in infectious disease ...
Breaking Medicine Technology:
(Date:6/27/2017)... and London UK (PRWEB) , ... June 27, 2017 , ... ... to a clinical study is whether they can trust the sponsor to pay them ... is vital that sponsors and CROs establish payment strategies that encourage sites to work ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... ... payment solution for many of the health care industry’s hospitals and provider groups, ... patient financing portal for select customers. Parasail Health is a San Francisco health-finance ...
(Date:6/27/2017)... ... June 27, 2017 , ... Building ... SUNucate efforts, Louisiana became the sixth state to pass legislation which ensures that ... Bel Edwards’ signature, Louisiana joins the states of Alabama, Arizona, Florida, Utah and ...
(Date:6/27/2017)... (PRWEB) , ... June 27, 2017 , ... A January ... been projected to reach a staggering $6.81 billion by the year 2024 according to ... at a faster rate than those made from titanium. Los Angeles area clinic Beverly ...
(Date:6/27/2017)... ... 2017 , ... The Kelahan Agency, a privately owned firm ... southern New Hampshire, is teaming up with the New Horizons for New Hampshire ... the region. , New Horizons for New Hampshire provides a wealth of services ...
Breaking Medicine News(10 mins):