Saphris Approval History

  • FDA approved: Yes (First approved August 13th, 2009)
  • Brand name: Saphris
  • Generic name: asenapine
  • Company: Schering-Plough Corporation
  • Treatment for: Schizophrenia, Bipolar Disorder

Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

FDA Approval History for Saphris

DateArticle
Sep  7, 2010Approval Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets
Aug 14, 2009Approval Schering-Plough Announces FDA Approval of Saphris (asenapine)
Jul 30, 2009FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
Feb 20, 2009Schering-Plough Submits Response to FDA for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Jan 14, 2009FDA Issues Complete Response Letter for Saphris for Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Nov 26, 2007Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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