`
`
`Vanda Pharmaceuticals, Inc.
`Attention: Gunther Birznieks
`Research & Development Committee Member
`
`
`2200 Pennsylvania Ave NW, Suite 300E
`Washington, DC 20037
`
`
`Dear Gunther Birznieks:1
`
`GENERAL ADVICE
`
`Please refer to your supplemental new drug application (sNDA) dated June 2, 2023,
`
`received June 2, 2023, and your amendments, submitted under section 505(b) of the
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for Fanapt (iloperidone) tablets.
`
`
`We also refer to the April 2, 2024, approval letter for your June 2, 2023, supplement
`
`
`
`which provided for the addition of the following indication: acute treatment of manic or
`
`
`mixed episodes associated with bipolar I disorder in adults.
`
`We note that the incorrect PMR numbers were listed in the April 2, 2024, approval letter.
`
`
`The correct PMR numbers are as follows:
`
`4606-1
`
`Conduct a GLP juvenile animal study to assess the toxicology of
`
`
`iloperidone in juvenile rats to support clinical trials of iloperidone in the
`
`
`intended pediatric population ages 10 to <13 years.
`
`
`Final Protocol Submission: 04/2024
`
`Study Completion:
`04/2025
`Final Report Submission: 10/2025
`
`
`
`4606-2
`
`Conduct an open-label, multiple oral dose study to demonstrate the safety,
`tolerability, and pharmacokinetics of iloperidone in patients ages 10 to <13
`
`years with manic or mixed episode associated with bipolar I disorder.
`
`
`
`Draft Protocol Submission: 03/2025
`Final Protocol Submission: 07/2025
`
`Study Completion:
`07/2026
`Final Report Submission: 01/2027
`
`
`
`1 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 5366066
`
`
`
`NDA 022192/S-023
`Page 2
`
`4606-3
`
` Conduct an open-label study to assess the long-term safety of iloperidone
`
`in patients aged 10 to <13 years with bipolar I disorder.
`
`
`
`Draft Protocol Submission: 03/2025
`Final Protocol Submission: 07/2025
`
`Study Completion:
`07/2030
`Final Report Submission: 01/2031
`
`
`
`Please disregard the PMR numbers listed in the April 2, 2024, approval letter.
`
`
`
`If you have any questions, contact Tiffanie Taylor, Regulatory Project Manager, at
`Tiffanie.Taylor@fda.hhs.gov.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Tiffany R. Farchione, MD
`Director
`Division of Psychiatry
`Office of Neuroscience
`
`Center for Drug Evaluation and Research
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5366066
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`TIFFANY R FARCHIONE
`04/17/2024 01:21:15 PM
`
`Reference ID: 5366066
`
`
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