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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, 2011Approval Invega Approved as Treatment for Schizophrenia in Adolescents
Aug  6, 2009Approval Invega Approved as the First and Only Treatment for Schizoaffective Disorder
Feb  6, 2009Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega
Aug 27, 2008FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia
Oct 29, 2007Elan 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, 2007Approval FDA Approves Invega for Long-Term Maintenance Treatment ofSchizophrenia
Dec 21, 2006Approval Invega Approved By FDA as New Treatment for Schizophrenia
Nov 10, 2006Janssen, L.P. Selects Invega (paliperidone) Extended Release Tablets as Brand Name for Its Investigational Atypical Antipsychotic
Sep 29, 2006FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia
Nov 30, 2005New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia

Further information

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