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( .I# I U.S. FOOD & DRUG
`
`,.,. .........
`•-..:::::i~
`
`ADMINISTRATION
`
`
` NDA 022334/S-051
`
` NDA 203985/S-023
`
`
`
`
`
`
`
`
`SUPPLEMENT APPROVAL
`
`
` Novartis Pharmaceuticals Corporation
`
` Attention: Shreyas Gupte
` Senior Global Program Regulatory Manager
`
`
` One Health Plaza
` East Hanover, NJ 07936-1080
`
`
`
`
`Dear Mr. Gupte:
`
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received
`
`
`
`
`August 2, 2021, 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) tablet for oral suspension.
`
`
`
`
`
`
`These Prior Approval sNDAs provide for the addition of lymphedema to the Adverse
`
`
`
`
`
`Reaction – Postmarketing Experience section of the Prescribing Information. In addition,
`
`
`minor editorial revisions were made to both the Prescribing Information and Patient
`
`Labeling.
`
`
`APPROVAL & LABELING
`
`
`
`
`
`We have completed our review of these applications, as amended. They are 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.
`
`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
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 4930274
`
`

`

`
`
`
` NDA 022334/S-051
`
` NDA 203985/S-023
`
`
` Page 2
`
`
`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 applications, you are exempt from this
`
`requirement.
`
`
`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
`
`
` 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: 4930274
`
`

`

`
` NDA 022334/S-051
`
` NDA 203985/S-023
`
`
` 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
`
`
`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, contact Rashida Redd, Regulatory Project Manager, at
`
`
`301-796-5489 or Rashida.Redd@fda.hhs.gov.
`
`
`
`Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`Amna Ibrahim, MD
`
`Deputy Director
`
`Division of Oncology 1
`
`Office of Oncologic Diseases
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`ENCLOSURE(S):
`
`
`• 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: 4930274
`
`

`

`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/
`------------------------------------------------------------
`
`AMNA IBRAHIM
`02/01/2022 10:47:41 AM
`
`Reference ID: 4930274
`
`(
`
`
`
`

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