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` NDA 21266/S-048
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` NDA 21267/S-058
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`NDA 21630/S-037
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` SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` c/o Pfizer Inc.
` 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 March 2, 2020,
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`received March 2, 2020, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for the following:
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`NDA 21266/S-048
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`NDA 21267/S-058
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`NDA 21630/S-037
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`These Prior Approval supplemental new drug applications provide for the following revisions to
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`the prescribing information (PI):
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`VFEND (voriconazole) tablets, 50 mg and 200 mg
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`VFEND (voriconazole) for injection, 200 mg
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`VFEND (voriconazole) for oral suspension, 40 mg/mL
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`(1) Serious Exfoliative Cutaneous Adverse Reactions (5.5) has been revised to read
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`Severe Cutaneous Adverse Reactions (5.5) in the WARNINGS AND PRECAUTIONS
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`(5) section.
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`(2) Toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic
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`symptoms (DRESS) has been added to the Severe Cutaneous Adverse Reactions
`(5.5) subsection.
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`(3) DRESS has been added to the ADVERSE REACTIONS (6) section, Clinical Trials
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`Experience (6.1) subsection, Dermatological Reactions and the Postmarketing
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`Experience in Adult and Pediatric Patients (6.2) subsection, Adults.
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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. They are approved, effective on the date
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`of this letter, for use as recommended in the enclosed agreed-upon labeling.
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`Reference ID: 4666887
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` NDA 21266/S-048
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` NDA 21267/S-058
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` NDA 21630/S-037
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` Page 2
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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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at FDA.gov.1 Content of
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`labeling must be identical to the enclosed labeling (text for the Prescribing Information, Patient
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`Package Insert, and Instructions for Use), with the addition of any labeling changes in pending
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`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry SPL
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`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 changes
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`for these NDAs, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
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`changes approved in these supplemental applications, as well as annual reportable changes.
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`To facilitate review of your submission(s), provide a highlighted or marked-up copy that shows
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`all changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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`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
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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 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
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`Deputy Director
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`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): 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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` 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 Database
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` 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: 4666887
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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
`09/04/2020 01:37:41 PM
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`Reference ID: 4666887
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`(
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