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

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` NDA 022334/S-45
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` NDA 203985/17
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` Page 2
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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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` Capitalized words classifying race throughout the label as listed in FDA Guidance
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`to Industry: Collection of Race and Ethnicity Data in Clinical Trials
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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 FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information), with the addition of any labeling changes in pending “Changes
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`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`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
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`additional submission of content of labeling in SPL format is not required.
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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 the NDAs, 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 these supplemental application, as well
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`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
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`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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` 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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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
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`www.fda.gov
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`
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`Reference ID: 4549924
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`

`

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` NDA 022334/S-45
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` NDA 203985/17
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` Page 3
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` REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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` Because none of these criteria apply to your applications, you are exempt from this
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` requirement.
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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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`
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`{See appended electronic signature page}
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`
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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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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4549924
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`

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`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
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`Reference ID: 4549924
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`(
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