Johnson and Johnson names oral atypical anti-psychotic

Janssen, a wholly-owned subsidiary of Johnson & Johnson, has announced that its paliperidone extended release tablets, an oral atypical anti-psychotic for which it is currently seeking approval, will be known under the brand name Invega.

The drug has been assigned a two month class 1 review by the Food and Drug Authority (FDA), with a user fee goal date for action and new drug application (NDA) being December 20th.

In September 2006, the FDA sent an approval letter to the company, with the December 20th applying to the reply to this letter by JJRPD.

An NDA for authorisation to market Invega was first submitted to the FDA in November last year.

“Invega combines paliperidone with the patented Oros extended release technology developed by Alza,” the company reports.

Johnson & Johnson is also the parent company of Alza and JJPRD.

Also in September, Janssen presented data regarding paliperidone extended release tablets at the European College of Neuropsychopharmaology.

The company reported that for patients with schizophrenia-related insomnia, the drug notably improved sleep onset and continuity, as well as duration of sleep. Data showed that use of extended release paliperidone resulted in a reduction of over 30 minutes in the required for patients to fall asleep.