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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 22567/S-002
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`SUPPLEMENTAL APPROVAL
`RELEASE REMS REQUIREMENT
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`Forest Laboratories, Inc.
`Attention: Kimberly Fabrizio
`Vice President, Regulatory Affairs
`Five Science Park
`New Haven, CT 06511
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`Dear Ms. Fabrizio:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated May 16, 2011 (S-002),
`submitted pursuant to section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Viibryd (vilazodone hydrochloride) Tablets 10 mg, 20 mg, and 40 mg .
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`We acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment
`dated June 8, 2011.
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`This supplement (S-002) proposes to eliminate the requirement for the approved Viibryd
`(vilazodone hydrochloride) Tablets REMS.
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`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter.
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` RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Viibryd (vilazodone hydrochloride) Tablets was originally approved on January
`21, 2011. The REMS consists of a Medication Guide and a timetable for submission of
`assessments of the REMS.
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`You propose that FDA no longer require a REMS for Viibryd (vilazodone hydrochloride)
`Tablets.
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`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
`element of the approved REMS to ensure that the benefits of Viibryd (vilazodone hydrochloride)
`Tablets outweigh its risks.
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`Reference ID: 2967500
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`NDA 22567/S-002
`Page 2
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`Therefore, we agree with your proposal and a REMS for Viibryd (vilazodone hydrochloride)
`Tablets is no longer required.
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`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, please email CDR Bill Bender, Senior Regulatory Project Manager, at
`william.bender@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, M.D.
`Director
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`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Reference ID: 2967500
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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/
`----------------------------------------------------
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`THOMAS P LAUGHREN
`06/29/2011
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`Reference ID: 2967500
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