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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21266/S-039
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` NDA 21267/S-050
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` NDA 21630/S-029
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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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` C.V. PF PRISM
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` c/o Pfizer, Inc.
` Attention: Nadia Kirzecky
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` Director, Pfizer Essential Health Global Regulatory Affairs Brands
`235 East 42nd Street
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`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 June 1, 2017, received June 1,
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`2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`Act (FDCA) for the following:
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`NDA 21266/S-039, VFEND (voriconazole) Tablets, 50 mg and 200 mg
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`NDA 21267/S-050, VFEND (voriconazole) Injection, 200 mg
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`NDA 21630/S-029, VFEND (voriconazole) for Oral Suspension, 40 mg/mL
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`We acknowledge receipt of your amendments dated November 29, 2018, which constituted complete
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`responses to our November 30, 2017, action letter.
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`These Prior Approval supplemental new drug applications provide for the addition of information
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`pertaining to voriconazole dosage and administration and safety in pediatric patients ages 2 to less than 12
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`years of age. The revised labeling contained in these supplements provides for the addition of pediatric
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`information to the following sections of the Prescribing Information (PI): HIGHLIGHTS OF
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`PRESCRIBING INFORMATION, INDICATIONS AND USAGE (1), DOSAGE AND
`ADMINISTRATION (2), WARNINGS AND PRECAUTIONS (5), ADVERSE REACTIONS (6),
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`USE IN SPECIFIC POPULATIONS (8), CLINICAL PHARMACOLOGY (12) and CLINICAL
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`STUDIES (14).
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`Minor revisions to the DOSAGE FORMS AND STRENGTHS (3), CONTRAINDICATIONS (4),
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`DRUG INTERACTIONS (7) and HOW SUPPLIED/STORAGE AND HANDLING (16) sections of
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`the PI and editorial/formatting revisions throughout the PI have also been made.
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`Additionally, the Patient Package Insert has been updated for consistency with the PI and the carton and
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`container labeling have also been updated.
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`Reference ID: 4383042
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` NDA 21266/S-039
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` NDA 21267/S-050
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` NDA 21630/S-029
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` Page 2
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` APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are approved,
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`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
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`[21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug
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`registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of
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`labeling must be identical to the enclosed labeling (text for the Prescribing Information and Patient
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`Package Insert), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`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
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`Standard for Content of Labeling Technical Qs and As” at
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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
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`NDAs, including CBE supplements for which FDA has not yet issued an action letter, with the content of
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`labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the changes approved in these
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`supplemental applications, as well as annual reportable changes. To facilitate review of your
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`submission(s), provide a highlighted or marked-up copy that shows all changes, as well as a clean
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`Microsoft Word version. The marked-up copy should provide appropriate annotations, including
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`supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed carton and container
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`labeling as soon as they are available, but no more than 30 days after they are printed. Please submit
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`these labeling electronically according to the guidance for industry titled Providing Regulatory
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`Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related
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`Submissions Using the eCTD Specifications (April 2018, Revision 5). For administrative purposes,
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`designate these submissions “Final Printed Carton and Container Labeling for approved
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`NDAs 21266/S-039, 21267/S-050, 21630/S-029.” Approval of these submissions by FDA is not required
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`before the labeling is used.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional labeling. To
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`do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the
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`Reference ID: 4383042
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` NDA 21266/S-039
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` NDA 21267/S-050
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` NDA 21630/S-029
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` Page 3
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` proposed materials in draft or mock-up form with annotated references, and (3) the Prescribing
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` Information to:
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` OPDP Regulatory Project Manager
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` Food and Drug Administration
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` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
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` Beltsville, MD 20705-1266
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` Alternatively, you may submit a request for advisory comments electronically in eCTD format. For more
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` information about submitting promotional materials in eCTD format, see the draft Guidance for Industry
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` (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM4437
`02.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a Form FDA
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`2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is
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`available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
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`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For more
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`information about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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
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`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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`Sumathi Nambiar, MD, MPH
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`Director
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`Division of Anti-Infective Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`Content of Labeling
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`Prescribing Information
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`Patient Package Insert
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`Carton and Container Labeling
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`Reference ID: 4383042
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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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`SUMATHI NAMBIAR
`01/29/2019 07:38:40 PM
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`Reference ID: 4383042
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