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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 22334/S-039
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`Food and Drug Administration
`Silver Spring MD 20993
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`sNDA APPROVAL
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`Novartis Pharmaceuticals Corporation
`Attention: Nina Katz, PhD
`Regulatory Affairs, Global Drug Development
`One Health Plaza
`East Hanover, NJ 07936
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`Dear Dr. Katz:
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`Please refer to your supplemental New Drug Application (sNDA) dated 13, 2017, received
`January 13, 2017, and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Afinitor (everolimus) Tablets.
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`This Prior Approval supplemental new drug application provides for:
`1. the use of a steroid-based mouthwash to reduce the incidence and severity of stomatitis
`from the use of Afinitor plus exemestane.
`2. addition of dose modification guidelines for hematological laboratory abnormalities and
`febrile neutropenia in the Dosage and Administration section.
`3. revisions to the section on Stomatitis and Embryo-Fetal Toxicity in Warnings and
`Precautions.
`4. revisions to sections on Females and Males of Reproductive Potential, Carcinogenesis,
`Mutagenesis, Impairment of Fertility and Patient Counseling Information.
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`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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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 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert). 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, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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`Reference ID: 4158621
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`NDA 22334/S-039
`Page 2
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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 new
`active ingredients, 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.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert,
`and patient PI (as applicable) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf).
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 4158621
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, MD
`Deputy Director
`Division of Oncology Products 1
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`NDA 22334/S-039
`Page 3
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`If you have any questions, call Alice Kacuba, at (301) 796-1381.
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`Enclosure(s):
`Content of Labeling
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`Reference ID: 4158621
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`AMNA IBRAHIM
`09/26/2017
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`Reference ID: 4158621
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