Risperdal FDA Approval History
FDA Approved: Yes (First approved December 29, 1993)
Brand name: Risperdal
Generic name: risperidone
Company: Janssen, L.P.
Treatment for: Schizophrenia, Bipolar Disorder, Autism
Risperdal (risperidone) is an atypical antipsychotic agent indicated for the treatment of schizophrenia, acute manic or mixed episodes associated with Bipolar I
Disorder and the treatment of irritability associated with autistic disorder.
Development timeline for Risperdal
Date | Article |
---|
May 18, 2009 | Approval FDA Grants Approval for Use of Risperdal Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder |
Feb 11, 2009 | FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder |
Oct 10, 2008 | Approval FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment |
Jul 24, 2008 | Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder |
Apr 14, 2008 | Supplemental New Drug Application for Risperdal Consta Submitted to
the FDA for the Treatment of Frequently Relapsing Bipolar Disorder |
Aug 22, 2007 | Approval FDA Approves Risperdal to Treat Adolescents with Schizophrenia andChildren and Adolescents with Bipolar Mania |
Jun 21, 2007 | FDA Issues Approvable Letter for Risperdal to Treat Adolescents
with Schizophrenia and Children and Adolescents with Bipolar Mania |
Apr 13, 2007 | Approval FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment |
Oct 6, 2006 | Approval FDA Approves Risperdal to Treat Irritability Associated with Autism |
Oct 29, 2003 | Approval Risperdal Consta Approved for Schizophrenia |
Dec 29, 1993 | Approval Risperdal Approved for Schizophrenia, Bipolar Mania |
Further information
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