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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22567/S-012
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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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` POSTMARKETING COMMITMENT FULFILLED
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`Forest Laboratories, Inc.
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`Attention: Michael Olchaskey, Pharm D.
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`Executive Director, Regulatory Affairs
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`Harborside Financial Center, Plaza V
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`Jersey City, NJ 07311
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`Dear Dr. Olchaskey:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received on May
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`16, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
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`for Viibryd (vilazodone hydrochloride) 10 mg, 20 mg, and 40 mg tablets.
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`We acknowledge receipt of your amendments dated July 14, 2014, July 23, 2014, September 18,
`2014, October 9, 2014, October 30, 2014, December 2, 2014, January 16, 2015, February 18,
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`2015, March 4, 2015, March 9, 2015, and March 11, 2015.
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`We also refer you to our January 21, 2011 Approval letter in which you agreed to explore lower
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`dose response for effectiveness as a postmarketing commitment (PMC# 1723-8).
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`This “Prior Approval” supplemental new drug application provides revisions to include a new
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`dosing regimen under the dosing and administration section of the Viibryd label.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`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
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
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`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`supplements, as well as annual reportable changes not included in the enclosed labeling.
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`Reference ID: 3716274
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` NDA 22567/S-012
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` Page 2
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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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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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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 includes labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your March 9, 2015, submission containing final printed carton and container
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`labels.
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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 new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`We are waiving the pediatric studies requirement for ages 0 to 6 years for the treatment of Major
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`Depressive Disorder (MDD) because necessary studies are impossible or highly impracticable
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`due to the low prevalence of this disease in these age ranges.
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`We are deferring submission of your pediatric studies for ages 7 to 17 years for the treatment of
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`MDD because this product is ready for approval use in adults and the pediatric studies have not
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`been completed.
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`Your deferred pediatric studies required by section 505B(a) of the Federal Food, Drug, and
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`Cosmetic Act are required postmarketing studies. The status of these postmarketing studies must
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`be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food,
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`Drug, and Cosmetic Act. These required studies were communicated in our approval letter dated
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`January 21, 2011.
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`Submit final reports to this NDA. For administrative purposes, all submissions related to this
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`required pediatric postmarketing study must be clearly designated “Required Pediatric
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`Assessment(s)”.
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`Reference ID: 3716274
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` Page 3
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`FULFILLMENT OF POSTMARKETING COMMITMENT
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`Your May 16, 2014 submission contains the final report for the following postmarketing
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`commitment listed in the January 21, 2011 approval letter.
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`1723-8 It is not apparent from the trials you have conducted in major depressive disorder
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`that the lowest effective dose of vilazodone has been identified, because only one
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`dose (40 mg/day) was studied. However, there are suggestions that 20 mg/day
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`may be effective at least in some subjects. In one of the trials, those who did not
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`tolerate 40 mg/day could continue in the trial on a dose of 20 mg/day, and some
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`may have had a significant treatment effect. In addition, data from the phase 2
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`fixed-dose trials suggest that there may have been a signal of efficacy with the 20
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`mg/day dose, as measured by the secondary efficacy measure (MADRS).
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`Moreover, some important adverse reactions are dose-related. Thus, we request
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`that you further characterize the efficacy and safety of vilazodone in the treatment
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`of adults with MDD using fixed doses of vilazodone (20 mg and 40 mg), an active
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`control (for assay sensitivity), and placebo in an adequate and well controlled trial.
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`We have reviewed your submission and conclude that the above commitment was fulfilled.
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`We remind you that there are postmarketing requirements and postmarketing commitments listed
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`in the January 21, 2011 approval letter that are still open.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`Food and Drug Administration
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`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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`Reference ID: 3716274
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` NDA 22567/S-012
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` Page 4
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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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`If you have any questions, please call CAPT William 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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`Mitchell V. Mathis, M.D.
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`CAPT, USPHS
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`Director
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`Division of Psychiatry Products
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`Office of Drug Evaluation I
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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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`Carton and Container Labeling
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`Reference ID: 3716274
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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
`03/16/2015
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`Reference ID: 3716274
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