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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203341/S-01
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Wyeth Pharmaceuticals, Inc.
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`Attention: Carl M. DeJuliis, Pharm.D.
`Director, Global Regulatory Affairs
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`500 Arcola Road
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`Collegeville, PA 19426-3982
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`Dear Dr. DeJuliis:
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` Please refer to your Supplemental New Drug Application (sNDA) dated April 30, 2013, received
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`April 30, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for BOSULIF® (bosutinib) Tablets, 100 mg and 500 mg.
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`We acknowledge receipt of your amendments dated, June 13, 2013, August 26, 2013,
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`September 6, 2013, and September 27, 2013.
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`This “Changes Being Effected” supplemental new drug application provides for updates to the
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`Dosage and Administration, Use in Special Populations, Clinical Pharmacology sections of the
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`package insert, and the Patient Leaflet, regarding patients with renal impairment
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`We note that your September 27, 2013, submission includes final printed labeling (FPL) for your
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`package insert, and patient package insert. We have not reviewed this FPL. You are responsible
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`for assuring that the wording in this printed labeling is identical to that of the approved content
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`of labeling in the structured product labeling (SPL) format.
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`Reference ID: 3381509
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` NDA 203341/S-01
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` Page 2
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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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert and text for the
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`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 includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement numbers and annual report dates.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Reference ID: 3381509
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` NDA 203341/S-01
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` Page 3
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` You must submit final promotional materials and package insert(s), accompanied by a Form
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` FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
` FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
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`instructions are provided on page 2 of the form. For more information about submission of
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`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
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`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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, call CAPT Diane Hanner, Regulatory Project Manager, at
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`(301) 796-4058.
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`Robert Kane, M.D.,
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`Deputy Director for Safety
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`Division of Hematology Products
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`Office of Hematology and Oncology Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3381509
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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/
`----------------------------------------------------
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`ROBERT C KANE
`09/30/2013
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`Reference ID: 3381509
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