`RESEARCH
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`
`
`APPLICATION NUMBER:
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`022567Orig1s000
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`REMS
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`Appendix A: Proposed REMS
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`Revised: 10 December 2010
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`NDA 22-567 vilazodone HCl Tablets
`
`Viibryd™
`(vilazodone hydrochloride)
`
`Class of Product: Antidepressant
`
`PGxHealth , LLC
`5 Science Park
`New Haven, CT 06511
`
`Contact Information: PGxHealth, LLC (1-877-878-7200)
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`RISK EVALUATION AND MITIGATION STRATEGY
`(REMS)
`
`
`Reference ID: 2871971
`Reference ID: 2894777
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`
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`Appendix A: Proposed REMS
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`
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`Revised: 10 December 2010
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`I. GOAL
`The goal of this REMS is to inform patients about the serious risks associated with the use of
`vilazodone HCl Tablets.
`
`
`Reference ID: 2871971
`Reference ID: 2894777
`
`
`
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`Appendix A: Proposed REMS
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`
`
`Revised: 10 December 2010
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`II. REMS ELEMENTS:
`A. Medication Guide
`PGxHealth, LLC, will ensure that a currently approved Medication Guide will be
`dispensed with each vilazodone prescription in accordance with 21 CFR 208.24.
`B. Timetable for Submission of Assessments
`PGxHealth, LLC, will submit REMS Assessments to FDA at 18 months, 3 years, and 7
`years from the date of the approval of the REMS. To facilitate inclusion of as much
`information as possible while allowing reasonable time to prepare the submission, the
`reporting interval covered by each assessment should conclude no earlier than 60 days
`before the submission date for that assessment. PGxHealth, LLC will submit each
`assessment so that it will be received by the FDA on or before the due date.
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`
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`Reference ID: 2871971
`Reference ID: 2894777
`
`
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`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ELLIS F UNGER
`01/21/2011
`
`Reference ID: 2894777
`
`