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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021660/S-036
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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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`Celgene Corporation
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`Attention: Renu Vaish, M.S.
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`400 Connell Drive
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`Suite 7000
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`Berkeley Heights, NJ 07922
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`Dear Ms. Vaish:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 14, 2012,
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`received December 14, 2012, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Abraxane®, Injectable Suspension (paclitaxel protein-bound particles
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`for injectable suspension (albumin-bound)) 100 mg/vial.
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`This “Prior Approval” supplemental new drug application provides for updates to the package to
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`update Section 6.1 “Clinical Trial Experience in Metastatic Breast Cancer” to include a
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`description of safety events: sepsis and neutropenic sepsis.
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`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert), with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`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
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`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf
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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 includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`Reference ID: 3320960
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` NDA 021660/S-036
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` Page 2
`changes approved in this supplemental application, as well as annual reportable changes and
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` 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
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` should provide appropriate annotations, including supplement number(s) and annual report
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` date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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` Food and Drug Administration
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` Center for Drug Evaluation and Research
` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
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` You must submit final promotional materials and package insert(s), accompanied by a Form
` FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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` FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
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`instructions are provided on page 2 of the form. For more information about submission of
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`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
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`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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Elleni Alebachew, Regulatory Project Manager, at
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`(301) 796 5225.
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`Sincerely,
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`{See appended electronic signature page}
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`Robert Justice, M.D.
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`Director
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`Division of Oncology Products 1
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`Office of Hematology and Oncology Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 3320960
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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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`ROBERT L JUSTICE
`06/07/2013
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`Reference ID: 3320960
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