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` NDA 217729
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` NDA APPROVAL
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`PF Prism C.V.
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`c/o Pfizer, Inc.
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`Attention: Aparna Srirangam, MS, PhD
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`Senior Manager, Pfizer Global Regulatory Affairs
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`10646 Science Center Drive
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`San Diego, CA 92121
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`Dear Dr. Srirangam:
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`Please refer to your new drug application (NDA) dated March 30, 2023, received March
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`30, 2023, and your amendments, submitted under section 505(b) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for BOSULIF (bosutinib) capsules.
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`This NDA provides for a new dosage form of bosutinib.
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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 date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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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, Patient Package Insert, and Instructions For Use) as well as
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`annual reportable changes not included in the enclosed labeling. Information on
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 5251024
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` NDA 217729
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`Page 2
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` 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 via publicly available labeling repositories.
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the carton and
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`container labeling submitted on September 26, 2023, as soon as they are available, but
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`no more than 30 days after they are printed. Please submit these labeling electronically
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`according to the guidance for industry SPL Standard for Content of Labeling Technical
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`Qs & As. For administrative purposes, designate this submission “Final Printed Carton
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`and Container Labeling for approved NDA 217729.” Approval of this submission by
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`FDA is not required before the labeling is used.
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`DATING PERIOD
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`Based on the stability data submitted to date, the expiry dating period for BOSULIF
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`(bosutinib) capsules shall be 36 months from the date of manufacture when stored at
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`20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) and
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`in the original package.
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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 this drug product for this indication has an orphan drug designation, you are
`exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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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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`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
`www.fda.gov
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`Reference ID: 5251024
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` NDA 217729
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`Page 3
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` Electronic Format—Promotional Labeling and Advertising Materials for Human
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` Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5
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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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`COMPENDIAL STANDARDS
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`A drug with a name recognized in the official United States Pharmacopeia or official
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`National Formulary (USP-NF) generally must comply with the compendial standards for
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`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
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`official USP monographs. More information on the USP-NF is available on USP’s
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`website6.
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`If you have any questions, email Brad McKenzie, Senior Regulatory Health Project
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`Manager, at bradley.mckenzie@fda.hhs.gov or call (301) 796-2583.
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`Sincerely,
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`{See appended electronic signature page}
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`R. Angelo de Claro, MD
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`Division Director
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`Division of Hematologic Malignancies I
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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`3 For the most recent version of a guidance, check the FDA guidance web page at
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`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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`6 https://www.uspnf.com/
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 5251024
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`NDA 217729
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`Page 4
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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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`Instructions For Use
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`o
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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: 5251024
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`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.
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`/s/
`------------------------------------------------------------
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`ROMEO A DE CLARO
`09/26/2023 01:51:28 PM
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`Reference ID: 5251024
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`(
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