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Home » Atypical Antipsychotic, FDA

Latuda

Submitted by on December 16, 2010 – 1:50 am | 1,419 views

FDA approves Latuda to treat schizophrenia in adults

The U.S. Food and Drug Administration today approved Latuda () tablets for the treatment of adults with schizophrenia.

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, , and . 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 These experiences can make people with the disorder fearful and withdrawn.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 . No drug in this class is approved to treat patients with .

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, and the urge to move (akathisia), , such as tremors, slow movement, or (), and .

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

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm

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