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FDA Issues Complete Response Letter for RISPERDAL(R) CONSTA(R) for the Adjunctive Maintenance Treatment of Bipolar Disorder
Date:2/10/2009

odstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., 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, visit http://www.janssen.com. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies.

RISPERDAL(R) CONSTA(R) (risperidone) is used for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL(R) CONSTA(R)

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

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of th
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
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