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`U.S. FOOD & DRUG
`ADMINISTRATION
`
`
`
` NDA 21266/S-053
`
` NDA 21267/S-063
`
`NDA 21630/S-042
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`
`
`
`
`
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`
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`SUPPLEMENT APPROVAL
`
`
` P.F. PRISM C.V.
`
`
` c/o Pfizer Inc.
` Attention: Alka Abrol
`
`
` Manager, Global Regulatory Affairs
`
` Hospital Business Unit
` Pfizer Biopharmaceutical Group
`
`
` 235 East 42nd Street
`
`
`New York, NY 10017
`
`
`
`
`Dear Ms. Abrol:
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`
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received
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`
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`April 28, 2022, and your amendment, submitted under section 505(b) of the Federal
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`
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`Food, Drug, and Cosmetic Act (FDCA) for the following:
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`NDA 021266/S-053 VFEND (voriconazole) tablets, 50 mg and 200 mg
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`NDA 021267/S-063 VFEND (voriconazole) for injection, 200 mg
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`NDA 021630/S-042 VFEND (voriconazole) for oral suspension, 40 mg/mL
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`These Prior Approval sNDAs provide for revisions to the prescribing information (PI) as
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`follows:
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`1) WARNINGS AND PRECAUTIONS (5) section, Photosensitivity (5.6)
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`subsection, and the ADVERSE REACTIONS (6) section, Clinical Trials
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`Experience (6.1) subsection, Skin and Appendages heading: text was added
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`regarding Bowen’s disease.
`2) DRUG INTERACTIONS (7) section: Updates regarding tyrosine kinase inhibitors
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`have been made to Table 11.
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`Additionally, minor editorial revisions were 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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`
`Reference ID: 5062239
`
`

`

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` NDA 21266/S-053
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` NDA 21267/S-063
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` NDA 21630/S-042
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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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`
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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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`
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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
`as annual reportable changes. To facilitate review of your submission(s), provide a
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`
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`
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`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
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`
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`supplement number(s) and annual report date(s).
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
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`supplement for the patent information to be timely filed (see 21 CFR
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`
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`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDAs that
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`require the submission of a request to remove patent information from the Orange Book
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`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`
`
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`Reference ID: 5062239
`
`

`

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` NDA 21266/S-053
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` NDA 21267/S-063
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` NDA 21630/S-042
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` Page 3
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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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`
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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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`
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`Sincerely,
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`
`
`{See appended electronic signature page}
`
`
`Dmitri Iarikov, MD, PhD
`
`Deputy Director
`
`Division of Anti-Infectives
`
`Office of Infectious Diseases
`
`Center for Drug Evaluation and Research
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`
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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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`Instructions for Use
`o
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`
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`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
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`Reference ID: 5062239
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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
`10/18/2022 10:30:34 AM
`
`Reference ID: 5062239
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`■
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`(
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