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INVEGA® Approved as Treatment for Schizophrenia in Adolescents
Date:4/11/2011

dverse Reactions: The most commonly observed adverse reactions in clinical trials occurring at an incidence of greater than or equal to 5% and at least 2 times placebo in the treatment of schizophrenia were: Adults – extrapyramidal symptoms, tachycardia, and akathisia; Adolescents (12-17 years of age) were: somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight increased and tachycardia. The most commonly observed adverse reactions in clinical trials occurring at an incidence of greater than or equal to 5% and at least 2 times placebo in the treatment of schizoaffective disorder were: Adults - extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about INVEGA® or your therapy, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About INVEGA®

INVEGA® (paliperidone) extended release tablets, an atypical antipsychotic medication, was approved in the U.S. in December 2006. Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets INVEGA®. It is approved for the treatment of schizophrenia in adults and adolescents (12-17 years of age) in the U.S. The efficacy of INVEGA® in schizophrenia was established in three six-week clinical trials in adults and in one six-week trial in adolescents (12-17 years of age), as well as in one maintenance trial in adults. INVEGA® is the only medication approved to treat schizoaffective disorder in adults. The efficacy of INVEGA® in schizoaffective disorder was established in two six-week trials in adults.

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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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