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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021660/S-041
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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: Pinky Doshi, MS, RAC
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` Director, Regulatory Affairs
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` 400 Connell Drive
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` Suite 7000
` Berkeley Heights NJ, 07922
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`Dear Ms. Doshi:
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`Please refer to your Supplemental New Drug Application (sNDA) dated January 12, 2015,
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`received January 12, 2015, submitted under section 505(b)/pursuant to section 505(b)(2) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Abraxane® for Injectable Suspension
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`(paclitaxel protein-bound particle for injectable suspension).
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`This Prior Approval supplemental new drug application proposes to 1) revise the preparation for
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`intravenous administration instruction and 2) incorporate data related to the use of Abraxane in
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`elderly patients with metastatic breast cancer.
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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
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`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
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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, text for the
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`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
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`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: 3793488
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, MD
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`Deputy Division 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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` NDA 021660/S-041
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` Page 2
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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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` 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-
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` 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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`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 Pamela Balcazar, Regulatory Project Manager, at (240) 402-4203.
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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 3793488
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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
`07/21/2015
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`Reference ID: 3793488
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