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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202570/S-013
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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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` PF PRISM C.V.
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` Attention: Melinda S. Meader
` Director, Worldwide Safety and Regulatory
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` Pfizer, Inc.
` 10646 Science Center Drive
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` San Diego, CA 92121
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`Dear Ms. Meader:
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`Please refer to your Supplemental New Drug Application (sNDA) dated September 23, 2014,
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`received September 23, 2014, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for XALKORI (crizotinib) Capsules, 250 mg and 200 mg.
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`We acknowledge receipt of your amendments dated March 13, 2015 and March 18, 2015.
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`This “Prior Approval” supplemental new drug application proposes to update the CLINICAL
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`PHARMACOLOGY, Pharmacodynamics subsection of the package insert to include QTc and
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`heart rate information.
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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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`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), with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`well as annual reportable changes not included in the enclosed 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
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`Reference ID: 3719195
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` NDA 202570/S-013
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` Page 2
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`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 number(s) and annual report
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`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
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this 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, call Ingrid Fan, Regulatory Project Manager, at (301) 796-5053.
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`Sincerely,
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`{See appended electronic signature page}
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`Jeffery Summers, M.D.
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`Deputy Director for Safety
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`Division of Oncology Products 2
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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: 3719195
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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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`JEFFERY L SUMMERS
`03/20/2015
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`Reference ID: 3719195
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