Risperdal 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 History and FDA Approval Process for Risperdal
|May 18, 2009|| 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|| 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|| 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|| FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment|
|Oct 6, 2006|| FDA Approves Risperdal to Treat Irritability Associated with Autism|
|Oct 29, 2003|| Risperdal Consta Approved for Schizophrenia|
|Dec 29, 1993|| Risperdal Approved for Schizophrenia, Bipolar Mania|
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