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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21660/S-037
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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
`Senior 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 March 21, 2013,
`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 May 21, 2013, June 6, 2013,
`June 17, 2013, June 19, 2013, June 28, 2013, July 12, 2013, August 9, 2013,
`August 13, 2013, September 3, 2013, September 4, 2013, and September 5, 2013.
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`This Prior Approval supplemental new drug application provides for a new indication for the
`first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination
`with gemcitabine.
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`APPROVAL & LABELING
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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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`WAIVER OF HIGHLIGHTS SECTION
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`Please note that we have previously granted a waiver of the requirements of
`21 CFR 201.57(d)(8) regarding the length of Highlights of prescribing information.
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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.
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`
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`Reference ID: 3369272
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`

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` NDA 21660/S-037
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`Page 2
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`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
`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
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`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 via 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 with the revisions
`indicated above 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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`Your March 21, 2013 and September 3, 2013, submissions contained proposed changes to the
`carton and container labels. The proposed changes are annual reportable changes which were
`not reviewed under the supplemental application for this NDA. Please submit the proposed
`carton and container labels changes in your next annual report in accordance with 21 CFR
`314.81(b)(2)(iii).
`
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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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`Because this drug product for this indication has an orphan drug designation, 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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`Reference ID: 3369272
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` NDA 21660/S-037
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`Page 3
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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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)].
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`Form 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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Meredith Libeg, Regulatory Project Manager, at (301) 796-1721.
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`Sincerely,
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`{See appended electronic signature page}
`
`Patricia Keegan, M.D.
`Division Director
`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
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`Reference ID: 3369272
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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
`09/06/2013
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`Reference ID: 3369272
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