FDAnews
www.fdanews.com/articles/86652-new-schizophrenia-drug-submitted-for-eu-approval

NEW SCHIZOPHRENIA DRUG SUBMITTED 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.