FDA ISSUES APPROVABLE LETTER FOR J&J'S SCHIZOPHRENIA DRUG

Johnson & Johnson (J&J) announced it has received an approvable letter from the FDA regarding a new drug application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia.

The company submitted an NDA to the FDA in November 2005. Upon approval by U.S. regulatory authorities, paliperidone ER, a new chemical entity, will be marketed in the United States by Janssen. The company also submitted a marketing authorization application for the drug to European health authorities in May. The submissions are based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries.

Paliperidone ER uses the OROS extended-release technology developed by ALZA. This technology provides a consistent release of medication over a 24-hour period leading to smooth blood plasma levels.