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FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:7/31/2009

d involuntary movements, and abnormal movements of the eyes.

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(R) SUSTENNA(TM) or your therapy, talk with your doctor.

About INVEGA(R) SUSTENNA(TM)

INVEGA SUSTENNA is approved for the acute and maintenance treatment of schizophrenia. It is the first once-monthly, long-acting, injectable atypical antipsychotic approved for this use in the U.S. INVEGA SUSTENNA is available in milligrams (mg) of paliperidone palmitate in dose strengths of 39 mg, 78 mg, 117 mg, 156 mg and 234 mg. Please be aware that clinical trial data presented at medical meetings were often reported as milligram equivalents (mg eq.) to paliperidone. Each dose of paliperidone palmitate is equivalent to a specific dose of paliperidone (39 mg, 78 mg, 117 mg, 156 mg and 234 mg of paliperidone palmitate is equivalent to 25 mg, 50 mg, 75 mg, 100 mg and 150 mg of paliperidone, respectively).

The pre-filled syringes require no reconstitution or refrigeration. Patients initiate treatment with two injections administered in the deltoid muscle one week apart (Day 1 at 234 mg and Day 8 at 156 mg), followed by injections every month thereafter administered in either the deltoid or gluteal muscle.

INVEGA SUSTENNA was developed utilizing Elan Drug Technologies' proprietary NanoCrystal(R) Technology. Using this technology increases the rate of dissolution and enables the formulation of an aqueous suspension for once-monthly intramuscular administration. INVEGA SUSTENNA is manufactured by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, in the U.S.

About J&JPRD

INVEGA SUSTENNA was developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&
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SOURCE Janssen
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