Invega
Generic name: paliperidone
Treatment for: Schizophrenia, Schizoaffective Disorder
New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia
TITUSVILLE, N.J., November 30, 2005 -- Johnson & Johnson Pharmaceutical Research & Development, LLC announced that it has submitted a New Drug Application to the United States Food and Drug Administration (FDA) for Paliperidone Extended-Release (ER) Tablets, an investigational extended- release, once daily, oral medication for the treatment of schizophrenia.
Paliperidone ER uses the patented OROS technology, which releases drug into the bloodstream steadily over a 24-hour period. Paliperidone ER will be marketed in the United States by Janssen, L.P., a wholly owned subsidiary of Johnson & Johnson. The trade name for the marketed product has not yet been determined.
The paliperidone ER filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Regulatory submissions are expected to follow for paliperidone ER in other countries.
Schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.
Source: Janssen, L.P.
Posted: November 2005
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- FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia - September 29, 2006
Invega (paliperidone) FDA Approval History
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