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NDA 022334/S-47
`
`
`NDA 203985/S20
`
`
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
` Novartis Pharmaceuticals Corp.
` Attention: Sara Lorie, MBA
`
`
`
` Global Therapeutic Area Lead-Global Health
` One Health Plaza, Bld 337/04/A18.3A
`
`
`
` East Hanover, NJ 07936-1080
`
`
`
`
`
`Dear Ms. Lorie:
`
`
`
`
`Please refer to your supplemental new drug applications (sNDA) dated and December
`
`
`
`
`16, 2020, and your amendments, submitted under section 505(b) of the Federal Food,
`
`
`
`
`
`Drug, and Cosmetic Act (FDCA) for Afinitor (everolimus) tablets and Afinitor Disperz
`
`(everolimus) tablets for oral suspension.
`
`
`
`
`
`
`These Prior Approval supplemental new drug applications provides for revisions to
`Section 5 Warnings and Precautions: Subsection 5.13 Radiation Sensitization and
`
`
`Radiation Recall, Section 6 Adverse Reactions: Subsection 6.2 Post Marketing
`Experience, and Section 17 Patient Counseling Information of the Full Prescribing
`
`Information (FPI) with corresponding changes to the Patient Package Insert, to add a
`
`
`
`new adverse reaction of Radiation Sensitization and Radiation Recall. In addition,
`
`Highlights of Prescribing Information was updated to reflect revisions made to the FPI
`
`and minor formatting edits were made throughout the FPI.
`
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. It is approved,
`
`
`
`
`effective on the date of this letter, for use as recommended in the enclosed agreed-
`
`upon labeling with minor editorial revisions listed below and reflected in the enclosed
`
`labeling.
`
`
`
`Correction to the cross-reference number for Embryo-Fetal Toxicity and the font
`
`
`
`
`
`
`for Radiation Sensitization and Radiation Recall in the Highlights of Prescribing
`
`
`Information.
`
`
`
`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: 4780931
`
`

`

`
`
`
`
`
`
` NDA 022334/S-47
`
`
`NDA 203985/S20
`
` 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 Food and Drug Administration (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).
`
`
`PROMOTIONAL MATERIALS
`
`
`
`You may request advisory comments on proposed introductory advertising and
`
`promotional labeling. For information about submitting promotional materials, see the
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`
`
`
` 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.
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
`
`
`
`
` https://www.fda.gov/media/128163/download.
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`
`
`Reference ID: 4780931
`
`

`

`
`
` NDA 022334/S-47
`
`
`NDA 203985/S20
`
` Page 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
`
`
`
`All promotional materials that include representations about your drug product must be
`
`promptly revised to be consistent with the labeling changes approved in this
`
`
`
`
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`
`
`
`in your promotional materials should include prominent disclosure of the important new
`
`
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`
`
`
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`
`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 you may contact Felicia Diggs, Safety Regulatory Project
`
`
`Manager, at (240) 402-4932 or via email at Felicia.diggs@fda.hhs.gov.
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Abhilasha Nair, M.D.
`
`
`Associate Director for Safety (acting)
`
`
`
`Office of Oncologic Diseases
`
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURES:
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Patient Package Insert
`
`
`
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4780931
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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/
`------------------------------------------------------------
`
`ABHILASHA NAIR
`04/16/2021 05:36:42 PM
`
`Reference ID: 4780931
`
`(
`
`
`
`

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