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`
`NDA 022334/S-004
`
`Novartis Pharmaceuticals Corporation
`
`Attention: Lincy Thomas, Pharm.D.
`
`Senior Associate Director, Drug Regulatory Affairs
`
`One Health Plaza
`
`East Hanover, NJ 07936-1080
`
`
`Dear Ms. Thomas:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) listed below, submitted under
`the Federal Food, Drug, and Cosmetic Act (FDCA) for AfinitorCI (everolimus)
`
`section 505(b) of
`
`
`Tablets.
`
`This Prior Approval Supplement provides for revising the package insert (PI) to include text for
`hepatitis B reactivation with fatal outcome in an ongoing clinical study (CRAD001C2324). This
`supplement proposes revisions to the following sections of the PI: 5 Warnings and Precautions,
`5.2 Infections, 5.5 Drug-drug Interactions; 6 Adverse Reactions; 17 Patient Counseling
`
`Information, 17.2 Infections, and Patient Information.
`
`
`We have completed our review of this supplemental application. It is approved, effective on the
`this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`date of
`
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of
`
`
`this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling (21 CFR
`314.50(1)) in structured product labeling (SPL) format, as described at
`http://v.lVlrw.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ detàul t.htm, that is
`identical to the enclosed labeling text for the package insert and patient package insert, and
`include the labeling changes proposed in any pending "Changes Being Effected" (CBE)
`supplements. Information on submitting SPL fies using eLIST may be found in the guidance for
`Labeling Technical Qs and As" at
`http://www . fda. gov I downloads/DrugsGui danccComp lianceRegulatoryInformation/Guidanccs/U
`CM072392.pdf.
`
`industry titled "SPL Standard for Content of
`
`
`The SPL wil be accessible from publicly available labeling repositories.
`
`

`

`NDA 022334/S-004
`2
`
`Page
`
`Also within 14 days, amend all pending supplemental applications for this NDA, including
`pending "Changes Being Effected" (CBE) supplements, for which FDA has not yet issued an
`action letter, with the content oflabeling (21 CFR 314.50(1)(1)(i)) in MS Word format that
`includes the changes approved in this supplemental application.
`
`PROMOTIONAL MATERIALS
`
`
`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(s)
`to:
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Division of Drug Marketing, Advertising, and Communications
`
`5901-B Ammendale Road
`
`Beltsvile, MD 20705-1266
`
`
`package insert(s), at the time of
`
`FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of
`
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`initial dissemination or publication, accompanied by a Form
`the Form. For
`more information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://wVlrw.fda.gov/AboutFDA/CentersOffices/CDERlucm090142.htm.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a "Dear Health Care Professional" letter), we request that you submit, at least
`the letter to this NDA, to
`CDERMedWatchSafetyAlerts~fda.hhs.gov, and to the following address:
`
`24 hours prior to issuing the letter, an electronic copy of
`
`
`MedWatch
`
`Food and Drug Administration
`
`Suite 12B-05
`
`5600 Fishers Lane
`
`Rockvile, MD 20857
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`

`

`NDA 022334/S-004
`Page 3
`
`
`If you have any questions, Amy Tiley, Regulatory Project Manager, at 301-796-3994.
`
`Sincerely,
`
`lSee appended electronic signature page)
`
`Robert L. Justice, M.D., M.S.
`
`Director
`
`Division of Drug Oncology Products
`
`Offce of Oncology Drug Products
`
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`
`F
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22334
`
`Submission
`Type/Number
`--------------------
`SUPPL-4
`
`Submitter Name
`
`Product Name
`
`--------------------
`NOVARTIS
`PHARMACEUTICA
`LS CORP
`
`------------------------------------------
`AFFINITOR
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ROBERT L JUSTICE
`07/09/2010
`
`