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Oct29
J&J Submits Paliperidone Palmitate for FDA Approval

Johnson & Johnson Pharmaceutical Research and Development has submitted paliperidone palmitate to the U.S. Federal Drug Administration for New Drug Application. Paliperidone palmitate is a once monthly antipsychotic intramuscular injection for the treatment of schizophrenia.

InvegaTo be marketed by Janssen L.P. upon FDA approval, the injection is a long acting injectable of the active ingredient Invega. It is estimated that 1 in 100 people develop schizophrenia, worldwide, and that over 2,000,000 people suffer from the disease in the U.S alone. The symptoms of the illness include hallucinations, delusions, depression, blunted emotions, disorganized thinking and social withdrawal.

Janssen, a subsidiary of J&J, is the only pharmaceutical company in the US that is dedicated solely to mental health. It currently markets prescription medications for the treatment of schizophrenia, bipolar mania and irritability associated with autism.

Common side effects include restlessness, involuntary movement, tremors and muscle stiffness. Uncommon side effects can include changes in heart rhythm, Tardive Dyskinesia, Neuroleptic Malignant Syndrome, increase in the hormone prolactin and increases in blood pressure and blood sugar.

For more information read Janssen's Press Release

 


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