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www.fdanews.com/articles/86619-janssen-cilag-submits-schizophrenia-drug-for-eu-approval

JANSSEN-CILAG SUBMITS SCHIZOPHRENIA DRUG FOR EU APPROVAL

May 8, 2006

Janssen-Cilag International has submitted a marketing authorization application to the European Medicines Evaluation Agency for a new, once-a-day drug to treat schizophrenia.

The drug, Paliperidone Prolonged Release Tablets, uses OROS technology to release the drug into the bloodstream steadily over a 24-hour period and has been tested to 1,600 people worldwide. The company said it has already filed for FDA approval and submissions in other countries will follow.

According to the announcement, schizophrenia affects an estimated one in every 100 people. Symptoms include hallucinations, delusions, depression, blunted emotions, social withdraw and disorganized thinking.