Invega FDA Approval History
FDA Approved: Yes (First approved December 19, 2006)
Brand name: Invega
Generic name: paliperidone
Company: Janssen, L.P.
Treatment for: Schizophrenia, Schizoaffective Disorder
Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder.
Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the treatment of schizophrenia and schizoaffective disorder.
Development timeline for Invega
| Date | Article |
|---|
| Apr 11, 2011 | Approval Invega Approved as Treatment for Schizophrenia in Adolescents |
| Aug 6, 2009 | Approval Invega Approved as the First and Only Treatment for Schizoaffective Disorder |
| Feb 6, 2009 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega |
| Aug 27, 2008 | FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia |
| Oct 29, 2007 | Elan Announces the Johnson & Johnson Pharmaceutical Research
& Development Submission of a New Drug Application to the FDA
for Paliperidone Palmitate Using Elan's Proprietary NanoCrystal
Technology |
| Apr 27, 2007 | Approval FDA Approves Invega for Long-Term Maintenance Treatment ofSchizophrenia |
| Dec 21, 2006 | Approval Invega Approved By FDA as New Treatment for Schizophrenia |
| Nov 10, 2006 | Janssen, L.P. Selects Invega (paliperidone) Extended Release Tablets as Brand Name for Its Investigational Atypical Antipsychotic |
| Sep 29, 2006 | FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia |
| Nov 30, 2005 | New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia |
Further information
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