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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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` NDA 021992/S-039
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`SUPPLEMENT APPROVAL/
`FULFILLMENT OF POSTMARKETING COMMITMENT
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`Pfizer Inc.
`Attention: Maria A. Pias
`Associate Director, Worldwide Regulatory Strategy
`445 Eastern Point Road
`Groton, CT 06340
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`Dear Ms. Pias:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received April 25,
`2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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` Pristiq (desvenlafaxine) 25 mg, 50 mg, 100 mg Extended-Release Tablets.
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`We acknowledge receipt of your amendments dated July, 18, 2014, July 28, 2014, and August 5,
`2014.
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`We also refer you to our February 29, 2008 Approval letter in which you agreed to explore lower
`dose response for effectiveness of lower strengths as a postmarketing commitment.
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`This supplemental new drug application provides for revisions to the labeling for Pristiq for the
`25 mg lower dose strength.
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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
`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
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`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 (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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`Reference ID: 3613249
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`NDA 021992/S-039
`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
`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 includes 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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`FULFILLMENT OF POSTMARKETING COMMITMENT
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`Your April 25, 2014 submission contains the final report for the following postmarketing
`commitment listed in the February 29, 2008 approval letter.
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`1229-2 Your NDA for desvenlafaxine succinate (DVS) demonstrates the effectiveness of doses
`as low as 50 mg as a treatment for Major Depressive Disorder (MDD), however, the
`available data for effectiveness for this drug in MDD suggests a flat dose response curve
`for efficacy between 50 and 400 mg/day. On the other hand, there is a clear dose
`response for adverse events as the dose increases from 50 to 400 mg/day. Therefore,
`there is a need to better understand the lower end of the dose response curve to
`determine if efficacy might be achieved at doses even lower than 50 mg/day. You have
`agreed to conduct and submit the results of a randomized controlled study including
`placebo and DVS doses of 10, 25, and 50 mg/day as a Postmarketing commitment. This
`study will assess efficacy in this dose range and will also include a validated and reliable
`outcome measure to assess for sexual dysfunction. You have agreed to submit the results
`of this trial no later than 3 years after the date of the approval for this NDA.
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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 is a postmarketing requirement listed in the February 29, 2008,
`approval letter that is still open.
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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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`Reference ID: 3613249
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`

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`NDA 021992/S-039
`Page 3
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`If you have any questions, email CAPT Bill Bender, Senior Regulatory Project Manager, 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.
`CAPT, USPHS
`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
`Carton Labeling
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`Reference ID: 3613249
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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
`08/20/2014
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`Reference ID: 3613249
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