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` NDA 021266/S-049
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` NDA 021267/S-059
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` NDA 021630/S-038
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`SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` c/o Pfizer Inc.
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` Attention: Anna Maria Gambino, MBA
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` Director, Global Regulatory Affairs
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` Hospital Business Unit
` Pfizer Biopharmaceutical Group
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` 235 East 42nd Street
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`New York, NY 10017
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`Dear Ms. Gambino:
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`Please refer to your supplemental new drug applications (sNDAs) dated May 7, 2020,
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`received May 7, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
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`NDA 021266/S-049 VFEND (voriconazole) tablets, 50 mg and 200 mg
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`NDA 021267/S-059 VFEND I.V. (voriconazole) for injection, 200 mg
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`NDA 021630/S-038 VFEND (voriconazole) for oral suspension, 40 mg/mL
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`These Prior Approval supplemental new drug applications provide for the following
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`revisions to the prescribing information (PI):
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`1) Contraindications (4) has been added to the HIGHLIGHTS OF PRESCRIBING
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`INFORMATION, RECENT MAJOR CHANGES, and the risk of adverse reaction
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`when coadministered with tolvaptan has been added under
`CONTRAINDICATIONS. This risk has also been added under FULL
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`PRESCRIBING INFORMATION, CONTRAINDICATIONS (4).
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`2) In the DRUG INTERACTIONS (7) section, information regarding the interaction
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`between voriconazole and letermovir has been added to the Effect of Other
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`Drugs on Voriconazole Pharmacokinetics (Table 10) and the interaction with
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`tolvaptan has been added to the Effect of Voriconazole on Pharmacokinetics
`of Other Drugs (Table 11).
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`3) In the CLINICAL PHARMACOLOGY (12) section, Pharmacokinetics (12.3)
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`subsection, information regarding letermovir has been added under Drug
`Interactions Studies, Effects of Other Drugs on Voriconazole and information
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`on tolvaptan has been removed from under the Effects of Voriconazole on
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`Other Drugs subheading.
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`Reference ID: 4735900
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`

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` NDA 021266/S-049
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` NDA 021267/S-059
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` NDA 021630/S-038
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` Page 2
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` 4) In the Patient Information, tolvaptan has been added to the Do not take VFEND
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` if you are taking any of the following medicines section.
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` Additionally, minor editorial revisions have been made throughout the PI.
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`APPROVAL & LABELING
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`We have completed our review of these 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-
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`upon labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information, Patient Package Insert, and Instructions for Use), with the
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`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
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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
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`changes for these NDAs, including CBE supplements for which FDA has not yet issued
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`an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in these supplemental applications, as well
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`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
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`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance Documents
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` Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4735900
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` NDA 021266/S-049
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` NDA 021267/S-059
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` NDA 021630/S-038
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` Page 3
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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`REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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` If you have any questions, call Alison Rodgers, Regulatory Project Manager, at
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` (301) 796-0797.
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` Sincerely,
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` {See appended electronic signature page}
`
` Dmitri Iarikov, MD, PhD
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` Deputy Director
` Division of Anti-Infectives
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` Office of Infectious Diseases
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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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` o Prescribing Information
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` o Patient Package Insert
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` o Instructions for Use
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4735900
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`

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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/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`01/25/2021 11:25:59 AM
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`Reference ID: 4735900
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`(
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