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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 021992/S-042
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`SUPPLEMENT APPROVAL/
`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
`Attention: Beatrice Curran, MS
`Director, Pfizer Essential Health Global Regulatory Affairs R&D
`235 East 42nd Street
`New York, NY 10017
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`Dear Ms. Curran:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received on April 6,
`2107, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Pristiq (desvenlafaxine) 25 mg, 50 mg, 100 mg Extended-Release
`Tablets.
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`This “Prior Approval” supplemental new drug application provides for pediatric data to fulfill
`the postmarketing study requirement (PMR 1229-1) imposed under the Pediatric Research
`Equity Act for the assessment of safety and efficacy in pediatric patients with Major Depressive
`Disorder.
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`APPROVAL & LABELING
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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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`We note that your February 5, 2018, submission includes final printed labeling (FPL) for your
`package insert and Medication Guide. We have not reviewed this FPL. You are responsible for
`assuring that the wording in this printed labeling is identical to that of the approved content of
`labeling in the structured product labeling (SPL) format.
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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
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`CONTENT OF LABELING
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`Reference ID: 4217426
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`

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`NDA 021992/S-042
`Page 2
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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 and 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
`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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`We note that you have fulfilled the pediatric studies requirement for all relevant pediatric age
`groups for this application.
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`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`Your April 6, 2017, submission contains the final report for the following postmarketing
`requirement listed in our February 29, 2008, approval letter.
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`1229-1 You have agreed to conduct studies to assess the safety and effectiveness of
`desvenlafaxine succinate as a treatment for Major Depressive Disorder in pediatric
`patients ages 7 to 17 (children and adolescents). Both children (ages 7 to 11 years)
`and adolescents (ages 12 to 17) will be equally represented in the samples, and there
`will be reasonable distribution of both sexes in these age strata.
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`Reference ID: 4217426
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`

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`NDA 021992/S-042
`Page 3
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`We have reviewed your submission and conclude that the above requirement was fulfilled.
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`This completes all your postmarketing requirements and postmarketing commitments
`acknowledged in our February 29, 2008, letter.
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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 William Bender, Senior Regulatory Project
`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.
`Director
`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: 4217426
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`

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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
`02/06/2018
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`Reference ID: 4217426
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`(
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