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 These experiences can make people with the disorder fearful and withdrawn.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:1/19/2017)... YORK , Jan. 19, 2017 This ... the current and future scenario of the global market. ... rising opioid consumption. Severe chronic constipation is a major ... to traditional laxatives. Hence, novel targeted therapy has been ... OIC sufferers, launch of targeted medicines, and growing awareness ...
(Date:1/19/2017)... 19, 2017  Stealth BioTherapeutics Inc. ( Stealth ), ... dysfunction, today announced new additions to its senior leadership ... Medical Officer, and Daniel Geffken as interim ... Jim Carr , Pharm.D. has been promoted to Chief ... to welcome Doug and Daniel to our management team, ...
(Date:1/19/2017)... January 19, 2017 According to a study ... is set to witness a CAGR of 6.5% during the forecast ... will continue to be the leading market for cryotherapy globally ... ... emphasizing on ensuring affordable and adequate supply of gas in order ...
Breaking Medicine Technology:
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... International Protein, ... nutritional and bodybuilding supplements, announced it attended the January ECRM trade show in Hilton ... and nutritional scientist who was determined to create a line of products that would ...
(Date:1/20/2017)... ... , ... “Mary Magdalene: Grace is Greater than Sin”: a unique and ... Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the creation of published ... with countless women who had little knowledge of the female characters portrayed in the ...
(Date:1/20/2017)... Farmville, NC (PRWEB) , ... January 20, 2017 ... ... the vPEP ® Oscillating Positive Expiratory Pressure (OPEP) device, was featured in ... article by Doug Pursley, MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive ...
(Date:1/20/2017)... ... 20, 2017 , ... “The Land of More and More”: a brilliant ... hunger, and shares the simple and achievable answer. “The Land of More and More” ... Fairview Missionary Church in Angola, Indiana where he works with the children’s ministry department. ...
(Date:1/19/2017)... ... 19, 2017 , ... Next week after January 20th, the fear for many ... that circumvent health needs of over 30 million. Many interviews with Dr. Carol Francis ... government public servants were suppose to prioritize. Interviews provided below. , Among ...
Breaking Medicine News(10 mins):