NDA 203341/S-026
`
`
`
`SUPPLEMENT APPROVAL
`
`
`PF Prism C.V.
`c/o Pfizer Inc.
`Attention: Brenda W. Kozan
`US Agent; Director, Pfizer Global Regulatory Sciences - Oncology
`500 Arcola Road
`Collegeville, PA 19426-3982
`
`
`Dear Brenda Kozan:
`
`Please refer to your supplemental new drug application (sNDA) dated June 10, 2024,
`received June 10, 2024, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for BOSULIF (bosutinib) tablets.
`
`This Prior Approval sNDA provides for an update to the United States Prescribing
`Information (USPI) in Section 6.1, Additional Adverse Reactions from Multiple Clinical
`Trials, to include the ADR terms of cardiac failure and cardiac ischemia.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`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(l)] 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 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.
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 5488737
`
`

`

`NDA 203341/S-026
`Page 2
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`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(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).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your supplemental application, you are exempt
`from this requirement.
`
`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: 5488737
`
`

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`NDA 203341/S-026
`Page 3
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`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 any questions, email Brad McKenzie, Senior Regulatory Health Project
`Manager, at bradley.mckenzie@fda.hhs.gov or call (301) 796-2583.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`R. Angelo de Claro, MD
`Division Director
`Division of Hematologic Malignancies I
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`Instructions for Use
`o
`
`
`
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5488737
`
`

`

`Signature Page 1 of 1
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`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/
`------------------------------------------------------------
`
`ROMEO A DE CLARO
`12/03/2024 11:11:44 AM
`
`Reference ID: 5488737
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`
`
`