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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Food and Drug
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`Administration Silver Spring
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`MD 20993
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`NDA 021992/S-015
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`Wyeth Pharmaceuticals, Inc.
`Attention: Kenneth R. Bonk
`Director II, Global Regulatory Affairs
`PO Box 8299
`Philadelphia, PA 19101-8299
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`Dear Mr. Bonk:
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`We acknowledge receipt of your supplemental new drug application dated and received June 3,
`2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Pristiq
`(desvenlafaxine) Extended-Release Tablets.
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`This supplemental application, submitted as a “Changes Being Effected” supplement, provides
`for revisions to include severe cutaneous reactions in the reference safety information section 6.3
`“Adverse Reactions Reported With Other SNRI’s”.
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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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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert) and include the labeling changes
`proposed in any pending “Changes Being Effected” (CBE) supplements. Information on
`submitting SPL files using eLIST may be found in the guidance for industry titled “SPL
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` 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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`SUPPLEMENT APPROVAL
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`(b) (4)
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`NDA 021992/S-015
`Page 2
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch
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`Food and Drug Administration
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`Suite 12B-05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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, call LCDR Juliette Toure, PharmD, at (301) 796-1924.
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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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`Application
`Type/Number
`--------------------
`NDA-21992
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`Submission
`Type/Number
`--------------------
`SUPPL-15
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`PRISTIQ (DESVENLAFAXINE)
`WYETH
`PHARMACEUTICA EXTENDED-RELEAS
`LS INC
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`THOMAS P LAUGHREN
`07/09/2010
`
`
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