NDA 22334/S-44
`NDA 203985/S-16
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Novartis Pharmaceuticals Corp.
`Attention: Smita Abbi, Ph.D.
`Senior Global Program Regulatory Manager
`Regulatory Affairs, Global Health - Oncology
`1 Health Plaza
`East Hanover, NJ 07936
`
`Dear Dr. Abbi:
`
`Please refer to your supplemental new drug applications (sNDAs) dated August 15,
`2019, received August 15, 2019, and your amendments submitted under section 505(b)
`
`of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) for AFINITOR
`(everolimus) tablets, for oral use and for AFINITOR DISPERZ® (everolimus tablets for
`oral suspension).
`
`These Prior Approval labeling supplemental new drug applications to retitle the
`WARNINGS AND PRECAUTIONS, (5.7) subsection of the prescribing information as
`Risk of Impaired Wound Healing and to state that AFINITOR/AFINITOR DISPERZ
`should be withheld for at least 1 week prior to elective surgery, that
`AFINITOR/AFINITOR DISPERZ should not be resumed for at least 2 weeks after major
`surgery and until adequate wound healing; and that the safety of resumption of
`AFINITOR/AFINITOR DISPERZ after wound healing complications was not known.
`Additionally, the Patient Counseling (17) section of the prescribing information and
`Patient Package Insert were updated to reflect changes in subsection 5.7.
`
`APPROVAL & LABELING
`
`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.
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`
`
`
`Reference ID: 4561408
`
`

`

`NDA 22334/S-44
`NDA 203985/S-16
`Page 2
`
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling text for the
`Prescribing Information and 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.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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 (which includes new salts and new fixed combinations), 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 in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`Reference ID: 4561408
`
`

`

`NDA 22334/S-44
`NDA 203985/S-16
`Page 3
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`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
`annotated references, and (3) the Prescribing Information to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD
`format. For more information about submitting promotional materials in eCTD format,
`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5 For more information
`about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see FDA.gov.6
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4561408
`
`

`

`NDA 22334/S-44
`NDA 203985/S-16
`Page 4
`
`
`If you have any questions, please call Sharon Sickafuse, Senior Regulatory Health
`
`Project Manager, at 301-796-2320 or email sharon.sickafuse@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Patricia Keegan, M.D.
`Associate Director for Medical Policy
`
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`ENCLOSURES:
`
` Content of Labeling
`
`o Prescribing Information
`
`o Patient Package Insert
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4561408
`
`

`

`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`PATRICIA KEEGAN
`02/13/2020 04:37:53 PM
`
`Reference ID: 4561408
`
`(
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