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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22567/S-011
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Forest Laboratories, Inc.
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`Attention: Kaity Posada, Pharm.D
`Director, Regulatory Affairs
`Harborside Financial Center, Plaza V
`Jersey City, NJ 07311
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`Dear Dr. Posada:
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`Please refer to your Supplemental New Drug Application (sNDA) dated November 20, 2013,
`received November 21, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Viibryd (vilazodone hydrochloride) 10 mg, 20 mg, and 40 mg tablets.
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`We acknowledge receipt of your amendment dated December 27, 2013.
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`This “Prior Approval” supplemental new drug application proposes to reimplement the reported
`percentage of serotonin syndrome in Section 5.2 Serotonin Syndrome; add in Section 6 Adverse
`Reaction cross-reference information to the Warnings and Precautions; and add a new section to
`Section 6.2 Post-Marketing Experience based on the cumulative review of spontaneous events.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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` CONTENT OF LABELING
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` As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
`well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 3484427
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`NDA 22567/S-011
`Page 2
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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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, email CAPT 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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`Mitchell V. Mathis, M.D.
`CAPT, USPHS
`Director
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`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3484427
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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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`MITCHELL V Mathis
`04/07/2014
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`Reference ID: 3484427
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