Janssen, L.P. Selects INVEGA(TM) (paliperidone) Extended Release Tablets As Brand Name For Its Investigational Atypical Antipsychotic

Main Category: Psychology / Psychiatry
Also Included In: Schizophrenia;  Depression;  Bipolar
Article Date: 11 Nov 2006 - 0:00 PDT

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Janssen, L.P., a wholly owned subsidiary of Johnson & Johnson, announced that it has selected INVEGA(TM) as the brand name for paliperidone extended release tablets, the company's investigational oral atypical antipsychotic. The company is seeking approval from the U.S. Food and Drug Administration (FDA) to market INVEGA(TM) for the treatment of schizophrenia.

The FDA recently informed the company that it has assigned a class 1 (i.e., two month) review for INVEGA(TM). The new user fee goal date for an FDA action on the new drug application (NDA) is now December 20, 2006.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD) submitted an NDA to the FDA in November 2005 seeking approval to market the drug, and in September the company received an approvable letter from the FDA. The December 20th action date applies to the response provided by JJPRD to the approvable letter that was issued by the FDA this September. Once approved by the FDA, INVEGA(TM) will be marketed in the U.S. by Janssen, L.P.

INVEGA(TM) combines paliperidone with the patented OROS extended-release technology developed by ALZA Corporation. ALZA, Janssen and JJPRD are wholly owned subsidiaries of Johnson & Johnson.

Based in Titusville, N.J., Janssen is the only large pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania and for the treatment of irritability associated with autistic disorder, including symptoms of aggression, deliberate self-injury, temper tantrums and quickly changing moods, in children and adolescents aged 5 to 16 years. The INVEGA(TM) submissions are based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries.

A global leader in pharmaceutical research and development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is committed to bringing to market high-value, cost-effective products that treat disease and significantly improve the health and lifestyles of people worldwide.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently two million people with schizophrenia, with men and women affected in equal proportions. The disease is characterized by hallucinations, delusions, depression, blunted emotions and social withdrawal, as well as disorganized thinking.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
http://www.janssen.com

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