`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 202570/S-11
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
` PF PRISM C.V.
`
`Attention: Melinda S. Meader
`Associate Director, Worldwide Safety & Regulatory
`Pfizer Inc.
`
`10646 Science Center Drive
`San Diego, CA 92121
`
`Dear Ms. Meader:
`
`Please refer to your Supplemental New Drug Application (sNDA) submitted January 15, 2014,
`received January 15, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Xalkori (Crizotinib) Capsules, oral, 200 mg, 250 mg.
`
`We acknowledge receipt of your amendments submitted on February 14, 2014, May 6, 2014, and
`May 20, 2014.
`
`This “Prior Approval” supplemental new drug application proposes to revise the Drug
`Interactions subsection of the Clinical Pharmacology section of the package insert to include
`information regarding the potential for crizotinib to inhibit uridine diphosphate glucuronosyl-
`transferase (UGT) enzymes and selected hepatic and renal transporters and to revise the
`Pregnancy and Pediatric Use subsections of the Use in Specific Populations section of the
`package insert to provide updated safety margins.
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`text.
`
`CONTENT OF LABELING
`
`
`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
`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.
`
`Reference ID: 3513754
`
`

`

`NDA 202570/S-11
`
`Page 2
`
`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/
`DrugsGuidanceCompliance RegulatoryInformation/Guidances/UCM072392.pdf
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`Also within 14 days, amend all pending supplemental applications that includes 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).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`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.
`
`Because this drug product for this indication has an orphan drug designation, you are exempt
`
`from this requirement.
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Mona Patel, Pharm.D., Regulatory Project Manager, at (301) 796-
`4236.
`
`Sincerely,
`{See appended electronic signature page}
`
`Jeffery Summers, M.D.
`Deputy Director of Safety
`Division of Oncology Products 2
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
`Content of Labeling
`
`
`
`Reference ID: 3513754
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JEFFERY L SUMMERS
`05/28/2014
`
`Reference ID: 3513754
`
`