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`
` NDA 022334/S-45
`
` NDA 203985/S-17
`
`
`
`
`
` CBE SUPPLEMENT –
`ACKNOWLEDGEMENT/APPROVAL
`
`
`
`
`Novartis Pharmaceuticals Corporation
`
`
`Attention: Smita Abbi
`
`Sr. Global Program Regulatory Manager
`
`One Health Plaza
`
`East Hanover, New Jersey 07936
`
`
`
`
`Dear Ms. Abbi:
`
`
`
`
`
`
`We have received your supplemental new drug applications (sNDAs) submitted under
`
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) for the
`
`following:
`
`NDA NUMBER:
`
`
`SUPPLEMENT NUMBER:
`
`
`PRODUCT NAME:
`
`
`NDA NUMBER:
`
`
`SUPPLEMENT NUMBER:
`
`
`PRODUCT NAME:
`
`
`
`022334
`
`
`45
`
`
`AFINITOR (EVEROLIMUS) TABLETS
`
`
`203985
`
`
`17
`
`
`
`
`AFINITOR DISPERZ (EVEROLIMUS) TABLETS FOR
`
`ORAL SUSPENSION
`
`
`
`DECEMBER 5, 2019
`
`
`
`DECEMBER 5, 2019
`
`
`DATE OF SUBMISSIONS:
`
`
`DATE OF RECEIPT:
`
`
`
`
`
`
`
`These supplemental applications, submitted as a “Changes Being Effected”
`
`supplement, proposes revision to Postmarketing Experience (6.2) subsection to include
`
`
`the following: Blood and lymphatic disorders: thrombotic microangiopathy.
`
`
`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-
`
`
`
`Reference ID: 4549924
`
`

`

`
` NDA 022334/S-45
`
` NDA 203985/17
`
` Page 2
`
`
`upon labeling, with minor editorial revisions listed below and reflected in the enclosed
`
`labeling.
`
`
`
` Capitalized words classifying race throughout the label as listed in FDA Guidance
`
`
`
`
`to Industry: Collection of Race and Ethnicity Data in Clinical Trials
`
`
`
`
`
`
`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), 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. If the content of labeling in SPL format initially submitted with
`this CBE-0 labeling supplement is identical to the attached approved labeling, an
`
`additional submission of content of labeling in SPL format is not required.
`
`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 the NDAs, 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 these 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).
`
`
`
`
` 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: 4549924
`
`

`

`
`
`
`
`
`
`
`
`
`
`
` NDA 022334/S-45
`
` NDA 203985/17
`
` Page 3
`
`
`
` 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(s) 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.
`
` 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
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`www.fda.gov
`
`Reference ID: 4549924
`
`

`

`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
`01/22/2020 01:47:44 PM
`
`Reference ID: 4549924
`
`(
`
`
`
`

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