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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21266/S-041
`NDA 21267/S-053
`NDA 21630/S-031
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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
`
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`Dear Ms. Kirzecky:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated December 19, 2016,
`received December 19, 2016, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`NDA 21266/S-041 VFEND (voriconazole) Tablets
`NDA 21267/S-053 VFEND I.V. (voriconazole) for Injection
`NDA 21630/S-031 VFEND (voriconazole) for Oral Suspension
`
`These Prior Approval supplemental new drug applications propose to update the VFEND
`package insert to be in compliance with the FDA Pregnancy and Lactation Labeling Rule
`(PLLR).
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`Additionally, the following changes have been made:
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`1. In HIGHLIGHTS, the established pharmacological class (EPC) has been revised in the
`INDICATIONS AND USAGE section, and the lactation information was removed
`from the USE IN SPECIFIC POPULATIONS section.
`2. The language for the drug-drug interaction between voriconazole and vinca alkaloids in
`the DRUG INTERACTIONS (7) section has been revised.
`3. The USE IN SPECIFIC POPULATIONS (8) section, Pediatric Use (8.4) subsection
`has been updated.
`4. The OVERDOSAGE (10) section has been updated.
`5. The CLINICAL PHARMACOLOGY (12) section, Pharmacodynamics (12.2) and
`Pharmacogenomics (12.5) subsections have been added.
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`Reference ID: 4112379
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`

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`NDA 21266/S-041
`NDA 21267/S-053
`NDA 21630/S-031
`Page 2
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`6. The CLINICAL PHARMACOLOGY (12) section, Pharmacokinetics (12.3) and
`Microbiology (12.4) subsections have been revised.
`7. The NONCLINICAL TOXICOLOGY (13) section, Teratogenic Effects (13.2)
`subsection has been removed.
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`Additionally, minor editorial changes have been made throughout the labeling.
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`APPROVAL & LABELING
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`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.
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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, text for the
`patient 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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`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.
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`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 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).
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`Reference ID: 4112379
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`

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`NDA 21266/S-041
`NDA 21267/S-053
`NDA 21630/S-031
`Page 3
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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.
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`Sincerely,
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`{See appended electronic signature page}
`
`Joseph Toerner, MD, MPH
`Deputy Director for Safety
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 4112379
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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/
`----------------------------------------------------
`
`JOSEPH G TOERNER
`06/15/2017
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`Reference ID: 4112379
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