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Saphris FDA Approval History

FDA Approved: Yes (First approved August 13, 2009)
Brand name: Saphris
Generic name: asenapine
Dosage form: Sublingual Tablets
Company: Allergan plc
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.

Development Timeline for Saphris

DateArticle
Mar 13, 2015Approval Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder
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 theU.S. FDA

Further information

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