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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21266/S-045
`NDA 21267/S-055
`NDA 21630/S-034
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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 D. Kirzecky
`Director, Pfizer Essential Health Global Regulatory Affairs Brands
`235 East 42nd Street
`New York, NY 10017
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`Dear Ms. Kirzecky:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated October 22, 2018, received
`October 22, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for the following:
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`NDA 21266/S-045, VFEND (voriconazole) tablets
`NDA 21267/S-055, VFEND (voriconazole) for injection
`NDA 21630/S-034, VFEND (voriconazole) for oral suspension
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`These Prior Approval supplemental new drug applications provide for revisions to the Instructions for
`Use as requested in the Agency’s Prior Approval Supplement Request letter to NDA 21630, dated August
`6, 2018.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. 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 Prescribing Information, Patient Package
`Insert, and Instructions for Use) 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
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`Reference ID: 4426509
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`NDA 21266/S-045
`NDA 21267/S-055
`NDA 21630/S-034
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM0723
`92.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 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 Microsoft Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes. To facilitate review of your
`submission(s), 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.
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`Sincerely,
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`{See appended electronic signature page}
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`Dmitri Iarikov, MD, PhD
`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
`Prescribing Information
`Patient Package Insert
`Instructions for Use
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`Reference ID: 4426509
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
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`DMITRI IARIKOV
`04/30/2019 04:11:16 PM
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`Reference ID: 4426509
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