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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21-372/S-017
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Eisai Inc.
`Attention: Stacie P. O’Sullivan
`Sr. Manager, Global Regulatory Affairs
`155 Tice Boulevard
`Woodcliff Lake, NJ 07677
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`Dear Ms. O’Sullivan:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`August 1, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Aloxi (palonosetron hydrochloride) injection.
`
`This “Changes Being Effected” supplemental new drug application provides for the addition of
`“hypersensitivity including anaphylaxis in patients without previous known hypersensitivity to
`other selective 5-HT3 receptor antagonists”, to the Warnings and Precautions and Adverse
`Reactions sections of the package insert.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. 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, 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.
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`Information on submitting SPL files using eList may be found in the guidance for 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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`Reference ID: 3448951
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` NDA 21-372/S-017
`Page 2
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`for this NDA, 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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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).
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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 Heather Buck, Regulatory Project Manager, at (301) 796-1413.
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`Sincerely,
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`{See appended electronic signature page}
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`Joyce Korvick, M.D., M.P.H.
`Deputy Director for Safety
`Division of Gastroenterology and Inborn Errors Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling
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`Reference ID: 3448951
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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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`JOYCE A KORVICK
`02/06/2014
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`Reference ID: 3448951
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