Navigation Links
FDA Approves Latuda to Treat Schizophrenia in Adults
Date:10/28/2010

SILVER SPRING, Md., Oct. 28 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

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

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness. Hearing voices that other people don't hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

"Schizophrenia can be a devastating illness requiring lifelong treatment," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available."

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).  

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

For information:

National Institute of Mental Health: Schizophrenia

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

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

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 Additional Medical Indication for Sprycel
2. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
3. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
4. FDA Approves Botox to Treat Chronic Migraine
5. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
6. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
7. FDA Approves Combination Contraceptive Containing a Folate
8. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
9. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
10. FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
11. FDA Approves Pediatric Use of Chemical Poisoning Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... professionals, announced today its affiliation with Tennessee Counseling Association. This new ... network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , ...
(Date:6/27/2016)... KS (PRWEB) , ... June 27, 2016 , ... TopConsumerReviews.com ... retailers of Eyeglasses . , Millions of individuals in the United States and ... have become a way to both correct vision and make a fashion statement. Even ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ... , "Film editors can give their videos a whole new perspective by using the ... CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
Breaking Medicine News(10 mins):