`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`
`NDA 21992/S-034
`
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
`
`Attention: Mary A. Pias
`
`Associate Director, Regulatory Strategy
`445 Eastern Point Road
`Groton, CT 06340
`
`Dear Ms. Pias:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated May 1, 2012, submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Pristiq
`(desvenlafaxine) Extended-Release 50 and 100 mg Tablets..
`
`We acknowledge receipt of your amendments dated August 10, 2012, and September 21, 2012.
`
`This “Prior Approval” supplemental new drug application provides for class labeling revisions to
`the Dosage and Administration, Contraindications, Warnings and Precautions, Drug
`Interactions, Patient Counseling Information, & Medication Guide regarding serotonin
`
`
`toxicity associated with the co-administration of linezolid and methylene blue as requested in an
`Agency supplement request letter dated March 5, 2012.
`
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text and with the minor editorial revisions agreed upon in an email communication dated
`December 5, 2012, between you and Paul David, of this Agency.
`
`
`CONTENT OF LABELING
`
`
`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 agreed upon in the September 24, 2012
`communication, the enclosed labeling (text for the 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.
`
`
`
`
`Reference ID: 3227645
`
`

`

` NDA 21992/S-034
`
`Page 2
`
`
`
`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 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).
`
`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, email CDR Juliette Touré, Pharm.D., Senior Regulatory Project
`Manager, at Juliette.Toure@fda.hhs.gov.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Mitchell V. Mathis, M.D.
`CAPT USPHS
`Director (acting)
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE: Content of Labeling
`
`
`
`
`Reference ID: 3227645
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`12/07/2012
`
`Reference ID: 3227645
`
`