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` NDA 21266/S-050
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` NDA 21267/S-060
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`NDA 21630/S-039
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` SUPPLEMENT APPROVAL
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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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`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
`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 and received August
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`14, 2020, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
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`and Cosmetic Act (FDCA) for the following:
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`NDA 21266/S-050
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`NDA 21267/S-060
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`NDA 21630/S-039
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`These Prior Approval supplemental new drug applications provide for revisions to the
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`prescribing information (PI) to include a contraindication for the use of ivabradine with
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`voriconazole and venetoclax, and text regarding the interaction between voriconazole with
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`ivabradine and venetoclax. Specifically, the following sections of the PI have been revised.
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`1) HIGHLIGHTS OF PRESCRIBING INFORMATION, under RECENT MAJOR CHANGES,
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`Contraindications (4) has been listed and text added under CONTRAINDICATIONS
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`2) FULL PRESCRIBING INFORMATION
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`a. DOSAGE AND ADMINISTRATION (2) section, Important Administration
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`Instructions for Use in All Patients (2.1) subsection
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`b. CONTRAINDICATIONS (4) section
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`c. DRUG INTERACTIONS (7) section, including Tables 10 and 11
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`d. CLINICAL PHARMACOLOGY (12) section, Pharmacokinetics (12.3) subsection,
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`Drug Interaction Studies subheading, under Effects of Other Drugs on
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`Voriconazole and Two-Way Interactions.
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`3) Minor editorial updates have been made throughout the PI including relocation of text
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`from subsection 12.3 Pharmacokinetics to Table 11 in DRUG INTERACTIONS (7) to
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`provide context for the recommended mitigation strategy and complete migration of drug-
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`drug interaction information.
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`4) Corresponding updates have been made to the Patient Information.
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`Reference ID: 4779670
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`

`

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` NDA 21266/S-050
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` NDA 21267/S-060
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` NDA 21630/S-039
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` Page 2
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` APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed agreed-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 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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`All promotional materials that include representations about your drug product(s) must be
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`promptly revised to be consistent with the labeling changes approved in these supplements,
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`including any new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional
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`materials should include prominent disclosure of the important new safety information that
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`appears in the revised labeling. Within 7 days of receipt of this letter, submit your statement of
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`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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` 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
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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
`
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`Silver Spring, MD 20993
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`www.fda.gov
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`
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`Reference ID: 4779670
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`

`

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` NDA 21266/S-050
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` NDA 21267/S-060
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` NDA 21630/S-039
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` Page 3
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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,
`
` {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 or Medication Guide
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`o Instructions for Use
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`
`
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`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4779670
`
`

`

`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
`04/15/2021 10:05:03 AM
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`Reference ID: 4779670
`
`(
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`
`