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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 203341/S-007
`NDA 203341/S-008
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING
` COMMITMENT
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`PF PRISM C.V.
`c/o Pfizer Inc.
`Attention: Jay B. Nair, PhD
`Global Regulatory Lead, Worldwide Safety and Regulatory
`500 Arcola Road
`Collegeville, PA 19426
`
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`Dear Dr. Nair:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated June 28, 2016 to
`Supplement 007, received June 28, 2016, and December 15, 2016 to Supplement 008, received
`December 15, 2016, and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for BOSULIF® (bosutinib) tablets, 100 and 500 mg.
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`The Prior Approval Supplement 007 provides for updates to the US Prescribing Information
`(USPI) Dosage and Administration section to include new dosing regimen. In addition, updates
`to the USPI Clinical Studies section related to the final study report and fulfillment of
`postmarketing commitment 1912-2: Continue follow-up of patients (on treatment and in
`protocol defined posttreatment follow-up) enrolled in Study 200-WW.
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`The Prior Approval Supplement 008 provides for updates to the USPI Adverse Reactions
`Postmarketing Experience section with the addition of Stevens Johnson’s syndrome information.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications., as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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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
`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
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`Reference ID: 4083804
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`

`

`NDA 203341/S-007
`NDA 203341/S-008
`Page 2
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, and text for the
`patient package insert), 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 titled
`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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
`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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. 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).
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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 new
`active ingredients, 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(s) in pediatric patients unless this requirement is waived,
`deferred, 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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`FULFILLMENT OF POSTMARKETING REQUIREMENT(S)/COMMITMENT(S)
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`We have received your submission dated June 28, 2016, containing the final report for the
`following postmarketing commitment listed in the September 4, 2012 approval letter.
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`PMC 1912-2 Continue follow-up of patients (on treatment and in protocol defined
`posttreatment follow-up) enrolled in Study 200-WW at least an additional 2 years
`past the March 28, 2011 cut-off date. Submit the Final Report, which will consist
`of an updated report containing, at a minimum, data through March 28, 2013.
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`
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`Final Report Submission: December 2015
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`Reference ID: 4083804
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`

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`NDA 203341/S-007
`NDA 203341/S-008
`Page 3
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`We have reviewed your submission and conclude that the above commitment was fulfilled.
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`This completes all of your postmarketing requirements and postmarketing commitments
`acknowledged in our September 4, 2012, letter.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Kimberly Scott, Regulatory Project Manager, at (240) 402-4560.
`
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`Sincerely,
`
`{See appended electronic signature page}
`
`Albert Deisseroth, MD, PhD
`Supervisory Associate Division Director
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
` Content of Labeling
`
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`Reference ID: 4083804
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ALBERT B DEISSEROTH
`04/13/2017
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`Reference ID: 4083804
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`