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Fanapt FDA Approval History

Last updated by Judith Stewart, BPharm on April 4, 2024.

FDA Approved: Yes (First approved May 6, 2009)
Brand name: Fanapt
Generic name: iloperidone
Dosage form: Tablets
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia, and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Development timeline for Fanapt

DateArticle
Apr  2, 2024Approval Vanda Pharmaceuticals' Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder
May  7, 2009Approval FDA Approves Fanapt to Treat Schizophrenia
Nov 20, 2008FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
Jul 28, 2008Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
Nov 27, 2007Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
Sep 27, 2007Vanda Pharmaceuticals Submits Iloperidone New Drug Application

See also

Fanapt (iloperidone) Consumer information

Further information

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