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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021992/S-043
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Pfizer Inc.
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`Attention: Maria A. Pias
`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 July 27,
`2016, 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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`We also refer to our Safety Labeling Change Notification letter dated June 8, 2016, notifying
`you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be
`included in the labeling for Pristiq (desvenlafaxine). This information pertains to the risk of
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`acute pancreatitis.
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`This supplemental new drug application provides for the addition of “Gastrointestinal Disorders
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`– Pancreatitis acute” to the Postmarketing Experience subsection (6.2) consistent with our June
`8, 2016 letter.
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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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`We note that your July 27, 2016, 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
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`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: 3977172
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`NDA 021992/S-043
`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
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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 (text for the package insert, 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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`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 Bill Bender, Senior Regulatory Project
`Manager, at (301) 796-2145 or via email at William.bender2@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell Mathis, M.D.
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`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
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`Reference ID: 3977172
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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
`08/26/2016
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`Reference ID: 3977172
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