`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
` NDA 21266/S-038
`
` NDA 21267/S-047
`
` NDA 21630/S-028
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
` PF Prism C.V.
`
` c/o Pfizer, Inc.
`
` Attention: Nadia Kirzecky
`
` Director, Worldwide Safety and Regulatory
`
`
`
` 235 East 42nd Street
` New York, NY 10017
`
`
`
`Dear Ms. Kirzecky:
`
`
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated August 6, 2014,
`
`
`
`
`received August 6, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`
`
`
`Cosmetic Act (FDCA) for the following:
`
`
`NDA 21266/S-038 VFEND (voriconazole) Tablets
`
`
`
`NDA 21267/S-047 VFEND I.V. (voriconazole) for Injection
`
`
`
`
`NDA 21630/S-028 VFEND (voriconazole) for Oral Suspension
`
`
`
`
`
`We acknowledge receipt of your amendment dated December 19, 2014.
`
`
`
`
`
`These “Prior Approval” supplemental new drug applications provide for revisions to the
`
`
`
`
`WARNINGS AND PRECAUTIONS section of the package insert with regard to Hepatic
`
`
`
`Toxicity, Arrhythmias and QT Prolongation, and Dermatological Reactions; the DOSAGE AND
`
`
`
`
`ADMINISTRATION section regarding concomitant use of voriconazole and blood products or
`
`
`
`short-term infusion of concentrated electrolytes; and the CLINICAL PHARMACOLOGY
`
`
`section, Microbiology subsection.
`
`
`In addition, editorial and administrative changes have been made to the labeling which include
`
`
`the correction of minor typographical errors, the addition of the Patient Counseling Information
`
`
`Statement in accordance with the FDA labeling guidance (February 2013), and the inclusion of
`
`
`
`Pfizer’s current standard text for all US labels. The Patient Information has also been updated to
`
`provide for changes consequential to the revisions to the Full Prescribing Information.
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3696601
`
`

`

`
`
`
`
`
` NDA 21266/S-038
`
` NDA 21267/S-047
`
` NDA 21630/S-028
`
` Page 2
`
`
` APPROVAL & LABELING
`
` 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.
`
`
`
` 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, 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.
`
`
`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 that includes 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).
`
`
`PROMOTIONAL MATERIALS
`
`
`
`
`All promotional materials that include representations about your drug product must be promptly
`
`
`
`
`revised to be consistent with the labeling changes approved in this supplement, including any
`
`
`
`
`
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`
`
`should include prominent disclosure of the important new safety information that appears in the
`
`
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`
`
`
`
`
`
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
`
`
`Reference ID: 3696601
`
`

`

`
` NDA 21266/S-038
`
` NDA 21267/S-047
`
` NDA 21630/S-028
`
` Page 3
`
`
` 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
`
`Director
`
`Division of Anti-Infective Products
`
`Office of Antimicrobial Products
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE:
`
`
`Content of Labeling
`
`Reference ID: 3696601
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`02/03/2015
`
`Reference ID: 3696601
`
`