NDA 022334/S-47
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`NDA 203985/S20
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`SUPPLEMENT APPROVAL
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` Novartis Pharmaceuticals Corp.
` Attention: Sara Lorie, MBA
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` Global Therapeutic Area Lead-Global Health
` One Health Plaza, Bld 337/04/A18.3A
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` East Hanover, NJ 07936-1080
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`Dear Ms. Lorie:
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`Please refer to your supplemental new drug applications (sNDA) dated and December
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`16, 2020, and your amendments, submitted under section 505(b) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for Afinitor (everolimus) tablets and Afinitor Disperz
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`(everolimus) tablets for oral suspension.
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`These Prior Approval supplemental new drug applications provides for revisions to
`Section 5 Warnings and Precautions: Subsection 5.13 Radiation Sensitization and
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`Radiation Recall, Section 6 Adverse Reactions: Subsection 6.2 Post Marketing
`Experience, and Section 17 Patient Counseling Information of the Full Prescribing
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`Information (FPI) with corresponding changes to the Patient Package Insert, to add a
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`new adverse reaction of Radiation Sensitization and Radiation Recall. In addition,
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`Highlights of Prescribing Information was updated to reflect revisions made to the FPI
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`and minor formatting edits were made throughout the FPI.
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`APPROVAL & LABELING
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`We have completed our review of these applications, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon labeling with minor editorial revisions listed below and reflected in the enclosed
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`labeling.
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`Correction to the cross-reference number for Embryo-Fetal Toxicity and the font
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`for Radiation Sensitization and Radiation Recall in the Highlights of Prescribing
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`Information.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`Reference ID: 4780931
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` NDA 022334/S-47
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`NDA 203985/S20
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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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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` the Food and Drug Administration (FDA) automated drug registration and listing system
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` (eLIST), as described at FDA.gov.1 Content of labeling must be identical to the
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`enclosed labeling (text for the Prescribing Information and Patient Package Insert), with
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`the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`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
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`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
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`supplement number(s) and annual report date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/media/128163/download.
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4780931
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` NDA 022334/S-47
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`NDA 203985/S20
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` Page 3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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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 you may contact Felicia Diggs, Safety Regulatory Project
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`Manager, at (240) 402-4932 or via email at Felicia.diggs@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Abhilasha Nair, M.D.
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`Associate Director for Safety (acting)
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4780931
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`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.
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`/s/
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`ABHILASHA NAIR
`04/16/2021 05:36:42 PM
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`Reference ID: 4780931
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`(
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