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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

DateArticle
May 18, 2009Approval 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, 2009FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder
Oct 10, 2008Approval FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment
Jul 24, 2008Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder
Apr 14, 2008Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
Aug 22, 2007Approval FDA Approves Risperdal to Treat Adolescents with Schizophrenia andChildren and Adolescents with Bipolar Mania
Jun 21, 2007FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Apr 13, 2007Approval FDA Approves New Dose of Risperdal Consta for SchizophreniaTreatment
Oct  6, 2006Approval FDA Approves Risperdal to Treat Irritability Associated with Autism
Oct 29, 2003Approval Risperdal Consta Approved for Schizophrenia
Dec 29, 1993Approval Risperdal Approved for Schizophrenia, Bipolar Mania

Further information

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