`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
` NDA 21-992/S-17
`
`
`
`
`
`
`
` SUPPLEMENT APPROVAL
`
`Wyeth Pharmaceuticals, Inc.
`Attention: Lauren E. Washam
`
`Regulatory Specialist I
`Worldwide Regulatory Strategy
`PO Box 8299
`Philadelphia, PA 19101-8299
`
`
`Dear Ms. Washam:
`
`We acknowledge receipt of your supplemental new drug application (sNDA) dated and received
`August 23, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Pristiq (desvenlafaxine succinate) Extended-Release Tablets.
`
`
`This Prior Approval supplement provides for revisions to the Medication Guide to include
`“important information concerning skin and subcutaneous tissue disorders such as angioedema
`
`contained in Section 6.2 Adverse Reactions Identified During Post-Approval Use of the
`
`physician text.”
`
`We have completed our review of this supplemental application and it is approved, effective on
`the date of this letter, for use as recommended in the enclosed labeling text.
`
`
`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 Medication Guide) 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 Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications for this NDA, including
`pending “Changes Being Effected” (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.
`
`
`
`
`
` NDA-21992 S-17
`
`Page 2
`
`
` REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call LCDR Juliette Toure, PharmD, at (301) 796-1924.
`
`
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Thomas Laughren, M.D.
`Director
`
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
`Content of Labeling
`
`
`
`
`
`Application
`Type/Number
`--------------------
`NDA-21992
`
`Submission
`Type/Number
`--------------------
`SUPPL-17
`
`Submitter Name
`
`Product Name
`
`------------------------------------------
`--------------------
`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/
`----------------------------------------------------
`
`MITCHELL V Mathis
`09/08/2010
`For Dr. Laughren
`
`