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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21660/S-031
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Abraxis BioScience, LLC, a wholly-owned subsidiary of Celgene Corporation
`Attention: Deborah Tady, PharmD, RPh, MBA, RAC
`Director, Global Regulatory Affairs
`9225 Indian Creek Parkway, Suite 900
`Overland Park, KS 66210
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`Dear Dr. Tady:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 9, 2011, and
`received on December 12, 2011, submitted pursuant to section 505(b)(2) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for ABRAXANE for Injectable Suspension (paclitaxel protein-
`bound particles for injectable suspension) (albumin-bound), 100 mg vial.
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`We acknowledge receipt of your amendments dated January 13, 2012; February 17, 2012; March
`2, 2012; March 9, 2012; March 30, 2012; May 9, 2012; July 12, 2012; August 2, 2012; August
`13, 2012; August 15, 2012; August 23, 2012; September 28, 2012; October 5, 2012; and October
`11, 2012.
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`This Prior Approval supplemental new drug application proposes to include a new indication for
`first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination
`with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
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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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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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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 and text for the
`patient package insert, with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 3202204
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`NDA 21660/S-031
`Page 2
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`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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`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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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the carton and immediate
`container labels submitted on October 11, 2012, as soon as they are available, but no more than
`30 days after they are printed.
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`Please submit these labels electronically according to the guidance for industry titled “Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved NDA 21660/S-
`031.” Approval of this submission by FDA is not required before the labeling is used.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`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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`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable because the disease/condition does not exist in children.
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`Reference ID: 3202204
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`NDA 21660/S-031
`Page 3
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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)
`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
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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, contact Monica Hughes, M.S., Lead Regulatory Project Manager, at
`(301) 796-9225.
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`Sincerely,
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`{See appended electronic signature page}
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`Patricia Keegan, M.D.
`Director
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`Division of Oncology Products 2
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 3202204
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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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`PATRICIA KEEGAN
`10/11/2012
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`Reference ID: 3202204
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