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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021660/S-025
`NDA 021660/S-026
`NDA 021660/S-029
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Celgene Corporation
`Attention: Renu Vaish, M.S.
`Executive Director, Global Regulatory Affairs
`Therapeutic Franchise Leader - Oncology Solid Tumors
`400 Connell Drive, Suite 7000
`Berkeley Heights, NJ 07922
`
`
`Dear Ms. Vaish:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated March 30, 2010,
`received March 30, 2010, June 1, 2010, received June 2, 2010, and July 25, 2011, received July
`25, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable
`suspension) (albumin-bound), 100 milligram vial.
`
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`We acknowledge receipt of your amendments dated December 8, 2010; February 25, 2011; July
`8, 2011; August 26, 2011; August 30, 2011; September 1, 2011; September 6, 2011; September 8
`(2), 2011; September 13, 2011; September 14, 2011; September 21, 2011, December 5, 2011;
`December 20, 2011, and December 22 (2), 2011.
`
`
`“Prior Approval” supplemental new drug application (S-025) provides for inclusion of pyrexia,
`dehydration, pancytopenia, congestive heart failure, and left ventricular dysfunction in Section 6,
`ADVERSE REACTIONS of the Package Insert.
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`“Prior Approval” supplemental new drug application (S-026) provides for revised labeling in the
`Physican Labeling Rule format.
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`“Prior Approval” supplemental new drug application (S-029) provides for inclusion of three
`adverse events: Stevens-Johnson syndrome, toxic epidermal necrolysis and extravasation in
`Section 6, ADVERSE REACTIONS of the Package Insert and minor administrative, editorial
`and grammatical revisions throughout the Package Insert.
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`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`
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`Reference ID: 3063210
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`

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` NDA 021660/S-025
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` NDA 021660/S-026
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` NDA 021660/S-029
`Page 2
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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 (text for the package insert, text for the
`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
`labeling.
`
`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. The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications 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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`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
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`
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`Reference ID: 3063210
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`

`

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` NDA 021660/S-025
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` NDA 021660/S-026
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` NDA 021660/S-029
`Page 3
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`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;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
`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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Yolanda Adkins, Regulatory Project Manager, at (301) 796-2850.
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`Sincerely,
`
`{See appended electronic signature page}
`
`
`Amna Ibrahim, M.D.
`Deputy Director
`Division of Oncology Products 1
`Ofice of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
`
`
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`Reference ID: 3063210
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`

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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
`12/23/2011
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`Reference ID: 3063210
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`