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`U.S. FOOD & DRUG
`ADMINISTRATION
`
`
`
`
` NDA 203341/S-024
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`
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`SUPPLEMENT APPROVAL
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`
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`
`
`
` PF Prism C.V.
`
` c/o Pfizer, Inc.
` Attention: Aparna Srirangam, MS, PhD
`
` Senior Manager, Pfizer Global Regulatory Affairs
`
`
` 10646 Science Center Drive
`
` San Diego, CA 92121
`
`
`
`
`
`Dear Dr. Srirangam:
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`
`
`Please refer to your supplemental new drug application (sNDA) dated February 1, 2023,
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`
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`received February 1, 2023, submitted under section 505(b) of the Federal Food, Drug,
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`and Cosmetic Act (FDCA) for Bosulif (bosutinib) tablets.
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`This Prior Approval sNDA provides for the addition of Interstitial Lung Disease (ILD) as
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`an Adverse Drug Reaction in Section 6.1 Clinical Trials Experience in the United States
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`Prescribing Information (USPI).
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`APPROVAL & LABELING
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`
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`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
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`labeling.
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`
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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 and Patient Package Insert), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 5161224
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`

`

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` NDA 203341/S-024
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` Page 2
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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 this NDA, including CBE supplements for which FDA has not yet issued an
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`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 this supplemental application, 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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
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`supplement for the patent information to be timely filed (see 21 CFR
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`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
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`require the submission of a request to remove patent information from the Orange Book
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`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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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
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
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`
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`
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`Reference ID: 5161224
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`

`

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` NDA 203341/S-024
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` Page 3
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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, email Brad McKenzie, Regulatory Project Manager, at
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`bradley.mckenzie@fda.hhs.gov or call (301) 796-2583.
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`
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`Sincerely,
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`
`
`{See appended electronic signature page}
`
`
`R. Angelo de Claro, MD
`
`Division Director
`
`
`Division of Hematologic Malignancies I
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`Office of Oncologic 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
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`
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`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 5161224
`
`

`

`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/
`------------------------------------------------------------
`
`ROMEO A DE CLARO
`04/20/2023 08:45:57 AM
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`Reference ID: 5161224
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`