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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 22567 / S-005
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Forest Laboratories, Inc.
`Attention: Debleena Sengupta, Ph.D., RAC
`Senior Manager, Regulatory Affairs
`Harborside Financial Center
`Plaza V, Suite 1900
`Jersey City, NJ 07311
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`Dear Dr. Sengupta:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated April 2, 2012,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Viibryd (vilazodone HCl) tablets.
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`We acknowledge receipt of your amendments dated August 6, 2012 and September 12, 2012.
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`These “Prior Approval” supplemental new drug applications provide for class labeling revisions
`to the Contraindications, Dosage And Administration, Warnings and Precautions, Drug
`Interactions, Use in Specific Populations, Patient Counseling Information, & Medication
`Guide regarding serotonin toxicity associated with the co-administration of linezolid and
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`methylene blue as well as revisions related to persistent pulmonary hypertension of the newborn
`as requested in Agency supplement request letters dated March 2 and March 5, 2012.
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text and with the minor editorial revisions agreed upon in an email communication
`dated December 19, 2012, between Kaity Posada and CAPT Steven D. Hardeman, of this
`Agency.
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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, except with the revisions agreed upon in the September 24, 2012
`communication, the enclosed labeling (text for the package insert, and Medication Guide), with
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`Reference ID: 3235494
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` NDAs 20822/S-043, 21046/S-020, 21323/S-040, & 21365/S-030
`Page 2
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`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
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`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 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, call Bill Bender, Senior Regulatory Project Manager, at (301) 796-
`2145.
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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 (acting)
`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: 3235494
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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
`12/21/2012
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`Reference ID: 3235494
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