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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202570/S-7
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` NDA 202570/S-9
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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 CV
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`C/O Pfizer Inc.
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`Attention: Mindy S. Meader, RAC
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`Associate Director
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`Worldwide Regulatory Strategy
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`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 Applications (sNDAs) S-7 dated April 30, 2013,
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`received April 30, 2013, and S-9 dated May 30, 2013, received May 31, 2013, submitted under
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`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Xalkori® (crizotinib)
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`250 mg and 200 mg capsules.
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`We acknowledge receipt of your amendments to S-7 dated May 23, July 15, August 6,
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`September 4 and September 30, 2013.
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`We acknowledge receipt of your amendments to S-9 dated September 4 and September 30, 2013.
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`S-7: This “Changes Being Effected” supplemental new drug application provides revisions to
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`the Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific
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`Populations and Clinical Pharmacology sections of the package insert to add information on
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`bradycardia and renal impairment.
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`S-9: This “Prior Approval” supplemental new drug application provides revisions to the Clinical
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`Pharmacology, Pharmacokinetics, Special Populations/Renal Impairment subsection (12.3), and
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`Patient Information section of the package insert based on the results of Study A8081020,
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`entitled “A Phase 1, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of
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`Crizotinib (PF-02341066) in Subjects with Impaired Renal Function.”
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`APPROVAL & LABELING
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`We have completed our review of these two supplemental applications, as amended. They are
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`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`Reference ID: 3385676
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`NDA 202570/S-7
` NDA 202570/S-9
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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 for the package insert, with the addition of
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as
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`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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`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 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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`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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`Reference ID: 3385676
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`NDA 202570/S-7
` NDA 202570/S-9
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` Page 3
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` Food and Drug Administration
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` Center for Drug Evaluation and Research
` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
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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
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`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`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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`All promotional materials that include representations about your drug product must be promptly
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`revised to be consistent with the labeling changes approved in this supplement, including any
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`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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`should include prominent disclosure of the important new safety information that appears in the
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`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
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`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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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 Missiratch Biable, Regulatory Project Manager, at (301) 796­
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`0154.
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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: 3385676
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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
`10/07/2013
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`Reference ID: 3385676
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