g iN U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`‘x
`
`NDA 21630/S-046
`
`SUPPLEMENT APPROVAL
`
`PF PRISM C.V.
`c/o PfizerInc.
`Attention: Nestor Duci, MBA
`Senior Manager, Pfizer Global Regulatory Sciences
`445 Eastern Point Road
`Groton, CT 06340
`
`Dear Nestor Duci:
`
`Please refer to your supplemental new drug application (SNDA) dated and received
`April 26, 2024, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA)for Vfend (voriconazole) for oral suspension.
`
`This Prior Approval sNDAprovidesfor
`
`ae
`updatesto the dosing
`information in the Prescribing Information (PI), Patient Package Insert (PPI) and
`Instructions for Use (IFU) to reflect the markings on the replacementsyringe.
`The updates madeto the PI were asfollows:
`
`DOSAGE AND ADMINISTRATION(2) section, Recommended Dosing Regimenin
`Adults (2.3) subsection and Recommended Dosing Regimenin Pediatric Patients
`(2.4) subsection: Updates were madeto add the Vfend oral suspension dosagefor
`adults and pediatric patients
`
`Additionally, minor editorial revisions were made throughoutthe PI.
`
`The PPI and the IFU were updatedto reflect changes madeto the PI.
`
`APPROVAL & LABELING
`
`Wehave completed our review of this application, as amended. It is approved, effective
`on the date ofthis letter, for use as recommendedin the enclosed agreed-upon
`labeling.
`
`CONTENT OF LABELING
`
`As soon aspossible, but no later than 14 days from the date ofthis letter, submit the
`contentof labeling [21 CFR 314.50(I)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`
`Reference ID: 5435918
`
`

`

`
`
`
` NDA 21630/S-046
`
` Page 2
`
`
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`
`
`
` Prescribing Information, Patient Package Insert and Instructions for Use), with the
` addition of any labeling changes in pending “Changes Being Effected” (CBE)
`
`
` supplements, as well as annual reportable changes not included in the enclosed
`
` labeling.
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`
`
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`changes for this NDA, 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 this supplemental application, as well as
`
`annual reportable changes. To facilitate review of your submission, 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).
`
`
`PROMOTIONAL MATERIALS
`
`
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`
`
`Electronic Format – Promotional Labeling and Advertising in Materials for Human
`
`Prescription Drugs.3
`
`
`
`
`You must submit final promotional materials and Prescribing Information, accompanied
`
`
`
`
`by a Form FDA 2253, at the time of initial dissemination or publication
`
`
`
`
`
`
`
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`Instructions for completing the form can be found at FDA.gov.5
`
`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
`
`
`
`
` 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
`
`
`
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page
` athttps://www.fda.gov/media/128163/download.
`
`
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 5435918
`
`

`

`
`
`
`
`
` NDA 21630/S-046
`
` Page 3
`
`
` 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).
`
`
`We remind you that you must comply with the requirements for an approved NDA set
`
`
`forth under 21 CFR 314.80 and 314.81.
`
`
`
`
`COMPENDIAL STANDARDS
`
`
`A drug with a name recognized in the official United States Pharmacopeia or official
`
`
`National Formulary (USP-NF) generally must comply with the compendial standards for
`
`
`
`strength, quality, and purity, unless the difference in strength, quality, or purity is plainly
`
`
`
`
`stated on its label (see FD&C Act § 501(b), 21 USC 351(b)). FDA typically cannot share
`application-specific information contained in submitted regulatory filings with third
`parties, which includes USP-NF. To help ensure that a drug continues to comply with
`compendial standards, application holders may work directly with USP-NF to revise
`official USP monographs. More information on the USP-NF is available on USP’s
`
`
`website6.
`
`
`
`
`
`
`
`If you have any questions, call Alison Rodgers, Senior Regulatory Project Manager, at
`
`301-796-0797.
`
`
`
`Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`Dmitri Iarikov, MD, PhD
`
`
`Deputy 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 Package Insert
`
`
`Instructions for Use
`o
`
`
`
`
`
` 6 https://www.uspnf.com/
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`Reference ID: 5435918
`
`

`

`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
`08/26/2024 01:31:43 PM
`
`Reference ID: 5435918
`
`(
`
`
`
`