`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
` NDA 21266/S-037
`
` NDA 21267/S-044
`
` NDA 21630/S-027
`
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
` PF Prism C.V.
`
` c/o Pfizer, Inc.
` Attention: Nadia Kirzecky
`
` Director, Worldwide Safety & Regulatory
`235 East 42nd Street
`
`
`
`New York, NY 10017
`
`
`
`
`
`Dear Ms. Kirzecky:
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated June 27, 2013, received June
`
`
`
`
`
`
`
`27, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for the
`
`following:
`
`
`NDA 21266/S-037
`
`NDA 21267/S-044
`
`NDA 21630/S-027
`
`
`
`We acknowledge receipt of your amendments dated December 11, and 17, 2013, January 14, and
`
`February 5, 2014.
`
`
`
`
`
`
`These “Prior Approval” supplemental new drug applications provide for revisions to the
`
`
`
`CONTRAINDICATIONS section and CLINICAL PHARMACOLOGY section, Pharmacokinetics
`
`
`
`
`
`
`subsection of the package insert regarding administration with efavirenz and everolimus.
`
`In addition, revisions have been made to the HIGHLIGHTS, CLINICAL PHARMACOLOGY section,
`
`
`
`
`Microbiology subsection, and NONCLINICAL TOXICOLOGY section.
`
`
`
`
`
`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), with the addition of any labeling
`
`
`
`
`
`
`
`
`
`VFEND (voriconazole) Tablets
`
`VFEND I.V. (voriconazole) for Injection
`
`
`
`VFEND (voriconazole) for Oral Suspension
`
`Reference ID: 3484978
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
` NDA 21266/S-037
`
` NDA 21267/S-044
`
` NDA 21630/S-027
`
` Page 2
`
`
` 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/UCM0723
`
` 92.pdf
`
` The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`
`
` 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).
`
`
` 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.
`
`
`
`
`
`
`
`
`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: 3484978
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`04/07/2014
`
`Reference ID: 3484978
`
`