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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021992/S-030
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer
`Attention: Maria Pias
`Associate Director
`Worldwide Regulatory Strategy, Pfizer
`PO Box 8299
`Philadelphia, PA 19101-8299
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`Dear Ms. Pias:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received October
`20, 2011, submitted under section 505(b)of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Pristiq (desvenlafaxine) 50 mg, 100 mg Extended-Release Tablets.
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`We also refer to the Agency’s “Changes Being Effected” supplement request letter sent to you
`on September 21, 2011, requesting revisions to add bruxism to section 6.2 Adverse Reactions
`Identified During Post-Approval Use as well as the addition of information to section 7.10 Drug
`Laboratory Test Interactions on false-positive urine immunoassay screening tests for patients
`taking Pristiq.
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`This “Changes Being Effected” supplemental new drug application proposes the addition of
`bruxism to section 6.1 Clinical Studies Experience under Psychiatric Disorders as well as the
`addition of information to section 7.10 Drug Laboratory Test Interactions on false-positive urine
`immunoassay screening tests for patients taking Pristiq.
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`In an email correspondence dated October 7, 2011, we agreed to your proposal to include
`bruxism in section 6.1 Clinical Studies Experience under Psychiatric Disorders, rather than in
`section 6.2, since the occurrence of bruxism was observed during clinical trials.
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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
`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, except with the revisions listed, the enclosed labeling (text for
`the package insert), with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 3098146
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`NDA 021992/S-030
`Page 2
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`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/DrugsGuidanceComplianceRegulatroyInformation/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 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, email Juliette Touré, Senior Regulatory Project Manager, at
`Juliette.Toure@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, M.D.
`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: 3098146
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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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`THOMAS P LAUGHREN
`03/07/2012
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`Reference ID: 3098146
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