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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21266/S-043
`NDA 21267/S-054
`NDA 21630/S-032
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`PF PRISM C.V.
`c/o Pfizer, Inc.
`Attention: Nadia Kirzecky
`Director, Pfizer Essential Health Global Regulatory Affairs Brands
`235 East 42nd Street
`New York, NY 10017
`
`
`Dear Ms. Kirzecky:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated July 19, 2017,
`received July 19, 2017, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for the following:
`
`NDA 21266/S-043 VFEND (voriconazole) Tablets
`NDA 21267/S-054 VFEND I.V. (voriconazole) for Injection
`NDA 21630/S-032 VFEND (voriconazole) for Oral Suspension
`
`These Prior Approval supplemental new drug applications provide for changes to the
`CLINICAL PHARMACOLOGY (12) section, Microbiology (12.4) subsection, and to the
`REFERENCES (15) section, of the prescribing information.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are 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 the enclosed labeling (text for the package insert), 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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`Reference ID: 4131615
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`
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`NDA 21266/S-043
`NDA 21267/S-054
`NDA 21630/S-032
`Page 2
`
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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.
`
`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 these NDAs, 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 these supplemental applications, 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, call Alison Rodgers, Regulatory Project Manager, at (301) 796-0797.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Dmitri Iarikov, MD, PhD
`Acting Deputy Director
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 4131615
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`
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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/
`----------------------------------------------------
`
`DMITRI IARIKOV
`07/28/2017
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`Reference ID: 4131615
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`
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