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
|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
|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|
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