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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`
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`NDA 21266/S035
`NDA 21267/S040
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`NDA 21630/S026
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`
`VFEND (voriconazole) Tablets
`VFEND I.V. (voriconazole) for Infusion
`VFEND (voriconazole) for Oral Suspension
`
`C.P. Pharmaceuticals International C.V.
`c/o Pfizer, Inc.
`Attention: Anthony Helstosky
`Director, Worldwide Regulatory Strategy
`235 East 42nd Street
`New York, NY 10017
`
`
`Dear Mr. Helstosky:
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated October 28, 2011,
`received October 28, 2011, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for:
`
`NDA 21266/S035
`NDA 21267/S040
`NDA 21630/S026
`
`These “Prior Approval” supplemental new drug applications provide for information on fluorosis
`and periostitis reported with postmarketing use of VFEND in the HIGHLIGHTS, WARNINGS
`AND PRECAUTIONS section and ADVERSE REACTIONS section, Postmarketing
`Experience subsection.
`
`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.
`
`
`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 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.
`
`
`Reference ID: 3045001
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`
`
`
` NDA 21266/S-035
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` NDA 21267/S-040
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` NDA 21630/S-026
`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.
`
`Also within 14 days, amend all pending supplemental applications 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).
`
`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 Alison Rodgers, Regulatory Project Manager, at (301) 796-0797.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Sumathi Nambiar, MD, MPH
`Deputy Director for Safety
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE:
`Content of Labeling
`
`Reference ID: 3045001
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUMATHI NAMBIAR
`11/16/2011
`
`Reference ID: 3045001
`
`
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