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`U.S. FOOD & DRUG
`ADMINISTRATION
`
`
` NDA 021266/S-054
`
` NDA 021267/S-064
`
` NDA 021630/S-043
`
`
`
`
`
`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:
`
`
`
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received
`
`June 07, 2022, and your amendments, submitted under section 505(b) of the Federal
`
`
`
`Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`
`
`
`NDA 021266/S-054 Vfend (voriconazole) tablets, 50 mg and 200 mg
`
`
`
`NDA 021267/S-064 Vfend (voriconazole) for injection, 200 mg
`
`
`
`NDA 021630/S-043 Vfend (voriconazole) for oral suspension, 40 mg/mL
`
`
`We also refer to our letter dated May 09, 2022, notifying you, under Section 505(o)(4) of
`
`
`the FDCA, of new safety information that we have determined should be included in the
`
`
`
`labeling for voriconazole. This information pertains to the risk of increased
`
`photosensitivity reactions associated with concomitant administration of voriconazole
`
`and methotrexate.
`
`
`
`
`These supplemental new drug applications provide for revisions to the labeling for
`
`
`Vfend products. The agreed upon changes to the language included in our May 09,
`2022, letter are as follows (additions are noted by double underline and deletions are
`
`
`noted by strikethrough):
`
`
`FULL PRESCRIBING INFORMATION
`
`
`5 WARNINGS AND PRECAUTIONS
`
`5.6 Photosensitivity
`
`
`
`
`
`In addition, VFEND has been associated with photosensitivity related skin reactions
`
`
`such as pseudoporphyria, cheilitis, and cutaneous lupus erythematosus, as well as
`
`
`
`
`
`Reference ID: 5030606
`
`

`

`NDA 021266/S-054
`NOA 021267/S-064
`NDA 021630/S-043
`
`Page 2
`
`41
`4
`increased risk of skin toxicity with concomitant use 9f methotrexate, a
`CbH l drugn
`u"~I There is the
`
`1
`_(b>~ -associated with ultraviolet (UV) reactivation ____
`potential for this risk to be observed with other drugs associated wilh U'V reactivation .
`Patients should avoid strong, direct sunlight during VFEND therapy.
`
`Other edits to reflect the changes are included in the following sections/subsections in
`the attached Prescribing Information (Pl):
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION, ADVERSE REACTIONS (6)
`section, Clinical Trials Experience (6.1), subsection under Clinical Trials Experience
`in Adults, Dermatological Reactions, Postmarketing Experience in Adult and
`Pediatric Patients (6.2) subsection, PATIENT COUNSELING INFORMATION (17)
`section and PATIENT INFORMATION.
`
`Other requested changes not required under section 505(o)(4) of the FDCA have been
`made to the PATIENT COUNSELING INFORMATION (17) section to add the following:
`
`Visual Disturbances
`
`Patients should be instructed that visual disturbances such as blurring and sensitivity to
`light may occur with the use of VFEND.
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are approved,
`effective on the date of this letter, for use as recommended in the enclosed agreed­
`upon labeling.
`
`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(1)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov. 1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Patient Information , Instructions for Use), with the addition of
`any labeling changes in pending "Changes Being Effected" (CSE) supplements, as well
`as annual reportable changes not included in the enclosed labeling.
`
`1 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabelinq/default.htm
`U.S. Food and Drug Administration
`Silver Spring , MD 20993
`www.fda.gov
`
`Reference ID 5030606
`
`

`

`
` NDA 021266/S-054
`
` NDA 021267/S-064
`
` NDA 021630/S-043
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`
`
`Page 3
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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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`
`
`
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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 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 Microsoft Word
`
`
`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
`
`
`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).
`
`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- related information [21 CFR 314.70(a)(4)]. The
`revisions in your promotional materials should include prominent disclosure of the
`
`important new safety-related information that appears in the revised labeling. Within 7
`days of receipt of this letter, submit your statement of intent to comply with
`
`
`
`21 CFR 314.70(a)(4).
`
`PATENT LISTING REQUIREMENTS
`
`
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`submitted in a supplement require you to submit patent information for listing in the
`
`Orange Book upon approval of the supplement. You must submit the patent information
`
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`
`supplement for the patent information to be timely filed (see 21 CFR
`
`
`
`
`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
`
`require the submission of a request to remove patent information from the Orange Book
`
`
`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`
`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
`
`
`
`
`
`
`
`
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`
`
`Reference ID: 5030606
`
`

`

`
` NDA 021266/S-054
`
` NDA 021267/S-064
`
` NDA 021630/S-043
`
`
`
`Page 4
`
`
` 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 questions, call Alison Rodgers, Regulatory Project Manager, at
`
`301-796-0797.
`
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Peter Kim, MD, MS
`
`Director
`
`Division of Anti-Infectives
`
`Office of Infectious Diseases
`
`Office of New Drugs
`
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`
`
`
`• Content of Labeling:
`
`
`o Prescribing Information
`
`
`
`o Patient information.
`
`
`Instructions for Use
`o
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 5030606
`
`

`

`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/
`------------------------------------------------------------
`
`PETER W KIM
`08/16/2022 08:37:59 AM
`
`Reference ID: 5030606
`
`