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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202324
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
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`Pfizer Inc.
`Attention: Alison Russell, PhD.
`Director, Worldwide Regulatory Strategy
`10646 Science Center Drive
`San Diego, CA 92121
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`Dear Dr. Russell:
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`Please refer to your New Drug Application (NDA) dated April 14, 2011, received
`April 14, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Inlyta® (axitinib) Tablets.
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`We acknowledge receipt of your amendments dated May 9, 16, and 27; June 10, 13, and 14;
`August 10; September 2, and 16; October 11, 21, 24, 27, and 28; November 1, 3, 29, and 30;
`December 9, 14, and 22, 2011; and January 3, 5, 24, and 26, 2012.
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`This new drug application provides for the use of Inlyta® (axitinib) for the treatment of advanced
`renal cell carcinoma after failure of one prior systemic therapy.
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`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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`Based on the provided stability data, an expiration dating period of 36 months is granted for the
`drug product when stored at room temperature 20°C to 25°C (68°F to 77°F); excursions
`permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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`WAIVER OF ½ PAGE.
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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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
`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
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`Reference ID: 3078397
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`

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`NDA 202324
`Page 2
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert). Information on submitting SPL files using eLIST may be found in the
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`guidance for industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the: enclosed carton and
`immediate container labels submitted on January 24, 2012, as soon as they are available, but no
`more than 30 days after they are printed. Please submit these labels electronically according to
`the guidance for industry titled “Providing Regulatory Submissions in Electronic Format –
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications (June 2008).” Alternatively, you may submit 12 paper copies, with 6 of the copies
`individually mounted on heavy-weight paper or similar material. For administrative purposes,
`designate this submission “Final Printed Carton and Container Labels for approved NDA
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`202324.” Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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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
`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.
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`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable. The disease does not exist in children.
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`POSTMARKETING COMMITMENTS NOT SUBJECT TO THE REPORTING
`REQUIREMENTS UNDER SECTION 506B
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`We remind you of your postmarketing commitments:
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`1868-1
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`Provide the analytical methods and method validation for testing of
`in the final drug substance.
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`The timetable you submitted on January 23, 2012, states that you will conduct this study
`according to the following schedule:
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`Reference ID: 3078397
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`and
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`(b) (4)
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`(b) (4)
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`NDA 202324
`Page 3
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`Final Report Submission: April 22, 2012
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`Submit clinical protocols to your IND 63662 for this product. Submit nonclinical and chemistry,
`manufacturing, and controls protocols and all study final reports to this NDA. In addition, under
`21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you should include a status summary of each
`commitment in your annual report to this NDA. The status summary should include expected
`summary completion and final report submission dates, any changes in plans since the last
`annual report, and, for clinical studies/trials, number of patients entered into each study/trial. All
`submissions, including supplements, relating to these postmarketing commitments should be
`prominently labeled “Postmarketing Commitment Protocol,” “Postmarketing Commitment
`Final Report,” or “Postmarketing Commitment Correspondence.”
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`PROMOTIONAL MATERIAL
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
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`information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see 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
`(21 CFR 314.80 and 314.81).
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`MEDWATCH-TO-MANUFACTURER PROGRAM
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`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at
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`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
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`Reference ID: 3078397
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`Sincerely,
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` {See appended electronic signature page}
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`Richard Pazdur, M.D.
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` Director
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`NDA 202324
`Page 4
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` .POST-ACTION FEEDBACK MEETING
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`New molecular entities and new biologics qualify for a post-action feedback meeting. Such
`meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
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` from successful aspects of the review process and to identify areas that could benefit from
`improvement. If you would like to have such a meeting with us, call the Regulatory Project
`Manager for this application.
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`If you have any questions, call Lisa Skarupa, Regulatory Project Manager, at (301) 796-2219.
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`ENCLOSURE(S):
`Content of Labeling
`Container Labeling
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`Reference ID: 3078397
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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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`RICHARD PAZDUR
`01/27/2012
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`Reference ID: 3078397
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