`NDA 22567/S-021
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`SUPPLEMENT APPROVAL/
`FULLFILLMENT OF POSTMARKETING REQUIREMENTS
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` Allergan Sales, LLC
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` Attention: Lenh Mong, ME, JD, RAC
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` Director, Regulatory Affairs
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` 5 Giralda Farms
` Madison, NJ 07940
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`Dear Mr. Mong:
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`Please refer to your supplemental new drug application (sNDA) dated and received on
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`August 1, 2019, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Viibryd (vilazodone hydrochloride) tablets.
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`This Prior Approval supplemental new drug application provides for the addition of
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`safety information in pediatric patients ages 7 years to 17 years of age with Major
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`Depressive Disorder.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4555169
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` NDA 22567/S-021
`Page 2
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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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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` supplement number(s) and annual report date(s).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`This product is appropriately labeled for use in all relevant pediatric populations.
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`Therefore, no additional pediatric studies are needed at this time.
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`FULFILLMENT OF POSTMARKETING REQUIREMENTS
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`We have received your submission dated August 1, 2019, containing the final reports
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`for the following postmarketing requirements listed in the January 21, 2011, approval
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`letter and January 17, 2018, new postmarketing requirement letter.
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`1723-3 Deferred pediatric study under PREA for the treatment of major
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`depressive disorder in pediatric patients aged 7 to 17. Conduct a second study to
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`obtain data on the efficacy and safety of vilazodone in the relevant pediatric
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`population. This must be a placebo-controlled and active-controlled (fluoxetine)
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`study. This study may be a fixed-dose study.
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`1723-12 Deferred pediatric study under PREA for the treatment of major
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`depressive disorder in pediatric patients aged 12 to 17. Conduct a study to obtain
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`data on the efficacy and safety of vilazodone in the relevant pediatric population.
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`This must be a placebo-controlled study. This study must be a fixed-dose study.
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`We have reviewed your submission and conclude that the above requirements were
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`fulfilled.
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`This completes all of your postmarketing requirements and postmarketing commitments
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`acknowledged in our January 21, 2011, and January 17, 2018 letters.
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` U.S. Food and Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4555169
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` NDA 22567/S-021
`Page 3
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
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`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
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`annotated references, and (3) the Prescribing Information to:
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` OPDP Regulatory Project Manager
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`Food and Drug Administration
` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
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` Beltsville, MD 20705-1266
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` Alternatively, you may submit a request for advisory comments electronically in eCTD
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`format. For more information about submitting promotional materials in eCTD format,
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`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5 For more information
`about submission of promotional materials to the Office of Prescription Drug Promotion
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`(OPDP), see FDA.gov.6
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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` 3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
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` version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4555169
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`NDA 22567/S-021
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`Page 4
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`If you have any questions, please contact CAPT Bill Bender, Senior Regulatory Project
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`Manager, at (301) 796-2145 or via email at william.bender@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Tiffany R. Farchione, M.D.
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`Director (Acting)
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`Division of Psychiatry
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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` U.S. Food and Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4555169
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`TIFFANY R FARCHIONE
`01/31/2020 03:55:40 PM
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`Reference ID: 4555169
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