( .I# I U.S. FOOD & DRUG
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`,.,. .........
`•-..:::::i~
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`ADMINISTRATION
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` NDA 021266/S-052
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` NDA 021267/S-062
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` NDA 021630/S-041
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`SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` c/o Pfizer Inc.
` Attention: Alka Abrol
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`
` Manager, Global Regulatory Affairs
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` Hospital Business Unit, Pfizer Biopharmaceutical Group
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` 100 Route 206 North
` New York, NY 07977
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`Dear Mr. Abrol:
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`Please refer to your supplemental new drug applications (sNDAs) dated and received
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`May 13, 2021, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for the following:
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`NDA 021266/S-052 VFEND (voriconazole) tablets, 50 mg and 200 mg
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`NDA 021267/S-062 VFEND (voriconazole) for injection, 200 mg
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`NDA 021630/S-041 VFEND (voriconazole) for oral suspension, 40 mg/mL
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`These Prior Approval sNDAs provide for revisions to the Prescribing Information (PI) to
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`include contraindications for the use of voriconazole with glasdegib, tyrosine kinase
`inhibitors, eszopiclone, and tretinoin. Specifically, the following sections and
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`subsections of the PI have been revised:
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`1) HIGHLIGHTS OF PRESCRIBING INFORMATION: Cisapride has been
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`removed from CONTRAINDICATIONS
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`2) FULL PRESCRIBING INFORMATION:
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`a. DOSAGE AND ADMINISTRATION (2) section, Recommended Dosing
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`Regimen in Adults (2.3) subsection: text has been modified.
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`b. CONTRAINDICATIONS (4) section: Cisapride has been removed.
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`c. DRUG INTERACTIONS (7) Table 11: lemborexant, glasdegib, tyrosine
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`kinase inhibitors, eszopiclone, and tretinoin have been added, and
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`cisapride was removed.
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`d. USE IN SPECIFIC POPULATIONS (8) section, Pregnancy (8.1)
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`subsection, Data subheading, under Animal Data: text has been modified,
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`“mg/m2 “ replaced with “body surface area comparison.”
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`e. NONCLINICAL TOXICOLOGY (13) section, Carcinogenesis,
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`Mutagenesis, Impairment of Fertility (13.1) subsection: text has been
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`modified, “mg/m2 “ replaced with “body surface area comparison.”
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`Reference ID: 4928508
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` NDA 021266/S052
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` NDA 021267/S-062
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` NDA 021630/S-041
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` Page 2
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`Additionally, minor editorial updates have been made throughout the PI including
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`replacement of the name “voriconazole” with “VFEND” and addition of the
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`manufacturer’s website at the end of the PI. Corresponding updates have been made to
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`the Patient Package Insert and the Instructions for Use.
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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
`as annual reportable changes. To facilitate review of your submission(s), provide a
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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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`supplement number(s) and annual report date(s).
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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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`Documents 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: 4928508
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` NDA 021266/S052
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` NDA 021267/S-062
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` NDA 021630/S-041
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` Page 3
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` PROMOTIONAL MATERIALS
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` All promotional materials that include representations about your drug product must be
` 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}
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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):
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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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`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: 4928508
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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
`01/28/2022 08:34:16 AM
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`Reference ID: 4928508
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`(
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