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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022567/S-019
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Forest Laboratories, LLC
`Attention: Nadia C. Success
`Manager, Regulatory Affairs
`Harborside Financial Center
`Plaza V, Suite 1900
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`Jersey City, NJ 07311
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`Dear Ms. Success:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received August 15,
`2016, 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 also refer to our Safety Labeling Change Notification letters dated May 31, 2016, and June
`8, 2016, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we
`believe should be included in the labeling for Viibryd (vilazodone). This information pertains to
`the risk of sleep paralysis and acute pancreatitis.
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`This supplemental new drug application provides for the addition of sleep paralysis and acute
`pancreatitis to the Post-marketing Experience subsection (6.2) consistent with our May 31,
`2016, and June 8, 2016 letters.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
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`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
`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, Medication
`Guide), 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
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`Reference ID: 3982141
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`NDA 022567/S-019
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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` The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include 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, please contact CAPT Bill Bender, Senior Regulatory Project
`Manager, at (301) 796-2145 or via email at William.bender2@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell Mathis, M.D.
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`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: 3982141
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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
`09/06/2016
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`Reference ID: 3982141
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