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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 022334/S-001
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`Novartis Pharmaceuticals Corporation
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`Attention: Lincy Thomas, PharmD
`Senior Associate Director, Drug Regulatory Affairs
`One Health Plaza
`East Hanover, NJ 07936-1080
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`Dear Ms. Thomas:
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`Please refer to your Supplemental New Drug Application (sNDA) dated July 30, 2009, received
`July 30, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Afinitor® (everolimus) 5 mg and 10 mg Tablets.
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`This Prior Approval supplemental new drug application provides for the replacement of the
` current food effect statement under Section 12.3, “Based on data in healthy subjects taking 1 mg
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`everolimus tablets, a high fat meal reduced Cmax and AUC by 60% and 16%, respectively. No
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` data are available with Afinitor 5 mg and 10 mg tablets.” with “In healthy subjects, high fat
`meals reduced systemic exposure to Afinitor 10 mg tablet (as measured by AUC) by 22% and
`the peak plasma concentration Cmax by 54%. Light fat meals reduced AUC by 32% and Cmax by
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`42%. Food, however, had no apparent effect on the post absorption phase concentration-time
`profile.”
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`We have completed our review of this supplemental 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, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling text for the package insert and for the patient package insert
`and include the labeling changes proposed in any pending “Changes Being Effected” (CBE)
`supplements. Information on submitting SPL files using eLIST may be found in the guidance for
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`industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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` NDA 022334/S-001
`Page 2
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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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`If you have any questions, call Amy Tilley, Regulatory Project Manager, at 301-796-3994.
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`Sincerely,
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` {See appended electronic signature page}
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`Robert L. Justice, M.D., M.S.
`Director
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`Division of Drug Oncology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling and Patient Information
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`Application
`Type/Number
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`NDA-22334
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`Submission
`Type/Number
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`SUPPL-1
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`Submitter Name
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`Product Name
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`--------------------
`NOVARTIS
`PHARMACEUTICA
`LS CORP
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`------------------------------------------
`AFFINITOR
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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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`ANTHONY J MURGO
`05/13/2010
`Anthony J. MD signing for:
`Robert L. Justice, M.D., M.S.
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