Navigation Links
FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania

TITUSVILLE, N.J., Aug. 22 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved RISPERDAL(R) (risperidone) for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.

This approval is based on studies involving more than 430 adolescents, ages 13-17, in the treatment of schizophrenia and 160 children and adolescents, ages 10-17, for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder.

RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by McNeil Pediatrics, a division of McNeil-PPC., Inc.

Janssen is the only U.S. pharmaceutical company exclusively dedicated to mental health. For more information about RISPERDAL, visit

RISPERDAL(R) (risperidone) is indicated in adults for the treatment of schizophrenia, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for the treatment of irritability associated with autistic disorder in ages 5-16 years, for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years.

Important Safety Information For RISPERDAL(R)

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

The most common adverse reactions observed in all clinical trials with Risperdal occurring at a rate of at least 10% were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.

A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL(R), is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.

You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your health care professional.

Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL(R). Some people may need regular blood sugar testing.

Some people taking RISPERDAL(R) may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional's dosing instructions, this side effect may be reduced or it may go away over time.

You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors and muscle stiffness. Some people taking RISPERDAL(R) have these side effects. If you have these symptoms, talk to your health care professional.

Some medications may interact with RISPERDAL(R). Avoid alcohol while on RISPERDAL(R).

Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL(R). Do not breastfeed if you are taking RISPERDAL(R).

RISPERDAL(R) may affect your driving ability, therefore, do not drive or operate machines before talking to your health care professional.

RISPERDAL(R) may affect alertness and motor skills; use caution until the effect of RISPERDAL(R) is known.

Please see full important U.S. prescribing information for RISPERDAL(R) at

Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania and irritability associated with autistic disorder. For more information about Janssen, L.P., visit, and for more information on RISPERDAL(R), visit

Johnson & Johnson Pharmaceutical Research and Development, L.L.C., is headquartered in Raritan, NJ, and has facilities throughout Europe and the U.S. The company is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

SOURCE Janssen, L.P.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. UW-Madison approves new research institute
2. FDA approves GEs heart-imaging technology
3. Senate approves bill to expand stem cell funding
4. FDA approves advanced digital mammography system
5. Building commission approves Institutes for Discovery
6. UW Board of Regents approves $134 million medical research facility
7. FDA approves Bone Cares Hectorol for treatment of kidney disease
8. Unique Surface Treatment of Novel TSK-GEL ODS Columns Provide Separation of Aqueous and Fat Soluble Vitamins
9. Improve Recovery and Reproducibility with Pre-Treatment of Analytical TSK-GEL G3000SWXL Size Exclusion Columns
10. Quintessence cancer treatment chosen for clinical studies
11. ConjuGon gets $730K to treat infections
Post Your Comments:
(Date:11/30/2015)... 2015 Partnership includes an MPP ... for the u niversity , s ... treatment s cale - up through ... Africa , where licensees based anywhere in the world will have ... --> Africa , where licensees based anywhere in the world ...
(Date:11/30/2015)... /PRNewswire/ - Zenith Epigenetics Corp. ("Zenith" or the "Company") today ... to its Board of Directors to replace Dr. ... wealth of experience as co-founder of Resverlogix, with expertise in ... --> --> Dr. Wong remarked, "I am ... Zenith,s long standing expertise in epigenetics and the advanced stage ...
(Date:11/30/2015)... Nov. 30, 2015  Champions Oncology, Inc. (CSBR), engaged ... to personalize the development and use of oncology drugs, ... Officer, will be presenting at the LD MICRO Investor ... Standard Time (PST).  The conference, held at the Luxe ... CA , will feature 200 small/micro-cap companies and ...
(Date:11/30/2015)... -- HUYA Bioscience International, the leader in accelerating global development ... announced it has signed a Memorandum of Understanding with ... between KDDF and HUYA with the ultimate goal of ... the global market. China,s ... preclinical and clinical stage compounds. The company advances the ...
Breaking Biology Technology:
(Date:11/10/2015)... Nov. 10, 2015 About ... that helps to identify and verify the identity ... considered as the secure and accurate method of ... a particular individual because each individual,s signature is ... especially when dynamic signature of an individual is ...
(Date:11/9/2015)... Nov. 9, 2015  Synaptics Inc. (NASDAQ: SYNA ... announced broader entry into the automotive market with a ... the pace of consumer electronics human interface innovation. Synaptics, ... ideal for the automotive industry and will be implemented ... Europe , Japan , ...
(Date:11/2/2015)... PARK, Calif. , Nov. 2, 2015  SRI ... $9 million to provide preclinical development services to the ... the contract, SRI will provide scientific expertise, modern testing ... wide variety of preclinical pharmacology and toxicology studies to ... --> The PREVENT Cancer Drug Development ...
Breaking Biology News(10 mins):