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` NDA 021266/S-047
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` NDA 021267/S-057
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` NDA 021630/S-036
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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
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` 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 March 2, 2020,
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`received March 2, 2020, 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-047 VFEND (voriconazole) tablets, 50 mg and 200 mg
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`NDA 021267/S-057 VFEND I.V. (voriconazole) for injection, 200 mg
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`NDA 021630/S-036 VFEND (voriconazole) for oral suspension, 40 mg/mL
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`These Prior Approval supplemental new drug applications provide for revisions to the following
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`sections of the Prescribing Information (PI):
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`1) HIGHLIGHTS OF PRESCRIBING INFORMATION, under RECENT MAJOR
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`CHANGES, Contraindications (4) and Warnings and Precautions (5.8) have been
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`added. Updates have also been made to DOSAGE FORMS AND STRENGTHS, under
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`For Oral Suspension, to CONTRAINDICATIONS regarding use with naloxegol, and in
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`WARNINGS AND PRECAUTIONS information added regarding Adrenal Dysfunction.
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`2) FULL PRESCRIBING INFORMATION, CONTRAINDICATIONS (4) section, addition of
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`contraindication when coadministered with naloxegol;
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`3) FULL PRESCRIBING INFORMATION, WARNINGS AND PRECAUTIONS (5) section,
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`addition of an Adrenal Dysfunction (5.8) subsection;
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`4) FULL PRESCRIBING INFORMATION, ADVERSE REACTIONS (6) section,
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`Postmarketing Experience in Adult and Pediatric Patients (6.2) subsection, addition
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`of an Endocrine disorders subheading and information regarding adrenal insufficiency
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`and Cushing’s syndrome;
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`5) FULL PRESCRIBING INFORMATION, DRUG INTERACTIONS (7) section, Effect of
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`Voriconazole on Pharmacokinetics of Other Drugs (Table 11), addition of information
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`regarding the interaction between voriconazole and naloxegol, prednisolone and other
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`corticosteroids, and ivacaftor;
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`6) FULL PRESCRIBING INFORMATION, CLINICAL PHARMACOLOGY (12) section,
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`Pharmacokinetics (12.3) subsection, under the Drug Interaction Studies, Effects of
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`Reference ID: 4731433
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`

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` NDA 021266/S-047
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` NDA 021267/S-057
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` NDA 021630/S-036
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` Page 2
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`Reference ID: 4731433
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` Voriconazole on Other Drugs subheading, addition of Naloxegol (CYP3A4 substrate)
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` information.
` 7) FULL PRESCRIBING INFORMATION, DOSAGE FORMS AND STRENGTHS (3)
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` section and HOW SUPPLIED/STORAGE AND HANDLING (16) section, How Supplied
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`(16.1) subsection, revisions to the description of the Powder for Oral Suspension;
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`Additionally, the text under the following sections of the Patient Package Insert (PPI) have been
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`updated to be consistent with the changes made in the PI:
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`• Do not take VFEND if you:
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`• Before you take VFEND, tell your healthcare provider about all of your medical
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`conditions, including if you:
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`• What are possible side effects of VFEND? VFEND may cause serious side effects
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`including:
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`• The most common side effects of VFEND in children include:
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`Further, a “bone problems” subsection has been added to the PPI and minor editorial revisions
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`have been made throughout labeling.
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`APPROVAL & LABELING
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`We have completed our review of these applications, as amended. They are approved, effective
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`on the 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, Instructions for Use), with the addition of any labeling changes in pending
`“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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` 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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` NDA 021266/S-047
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` NDA 021267/S-057
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` NDA 021630/S-036
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` Page 3
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` 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
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` appropriate annotations, including supplement number(s) and annual report date(s).
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. For information about submitting promotional materials, see the final guidance for
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`industry Providing Regulatory Submissions in Electronic and Non-Electronic Format-
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`Promotional Labeling and Advertising Materials for Human Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied by a
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`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at FDA.gov.4 Information and Instructions for completing the form can be
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`found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be promptly
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`revised to be consistent with the labeling changes approved in this supplement, including any
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`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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`should include prominent disclosure of the important new safety information that appears in the
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`revised labeling. Within 7 days of receipt of this letter, submit your statement of intent to comply
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`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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` 3 For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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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: 4731433
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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
`01/14/2021 02:31:42 PM
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`Reference ID: 4731433
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`(
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