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` NDA 203341/S-18
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`SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` Attention: Bhanu Purohit, M.S.
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` U.S. Agent Global Regulatory Lead
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` Pfizer Global Regulatory Affairs
` 445 Eastern Point Road MS 8260-1118
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` Groton, CT 06340
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`Dear Ms. Purohit:
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`Please refer to your supplemental new drug application dated and received February
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`20, 2020, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Bosulif (bosutinib) tablets.
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`This Prior Approval supplemental new drug application provides for revisions to Section
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`6 Adverse Reactions subsection 6.1 Clinical Trials Experience of the Prescribing
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`Information to include the adverse reactions of hypothyroidism and hyperthyroidism.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon labeling with minor
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`editorial revisions listed below and reflected in the enclosed labeling.
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`• Revised the date at the end of the Highlights of Prescribing Information to “6/2020”.
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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: 4626211
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` NDA 203341/S-18
` 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
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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
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`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
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`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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`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 you may contact Felicia Diggs, Safety Regulatory Project
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`Manager, at (240) 402-4932 or via email at Felicia.diggs@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Abhilasha Nair, M.D.
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`Associate Director for Safety (acting)
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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` 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.
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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: 4626211
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`NDA 203341/S-18
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`Page 3
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`ENCLOSURES:
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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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`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: 4626211
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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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`ABHILASHA NAIR
`06/17/2020 08:46:59 AM
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`Reference ID: 4626211
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`(
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