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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-660/S-010
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`Abraxis BioScience, Inc.
`Attention: Monica Batra
`Manager, Regulatory Affairs
`4503 Glencoe Ave.
`Marina Del Rey, CA 90292
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`Dear Ms. Batra:
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`Please refer to your supplemental new drug application dated April 14, 2006, received April 18, 2006,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for ABRAXANE® for
`Injectable Suspension (paclitaxel protein-bound particles for injectable suspension).
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`We acknowledge receipt of your submissions dated June 14 and 29; July 21 and December 5, 2006;
`January 15; February 9 and 14 (electronic), 2007.
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`This supplemental new drug application provides revised prescribing information with updated safety
`and efficacy information for ABRAXANE® Injectable Suspension (paclitaxel protein-bound particles
`for injectable suspension) in the treatment of breast cancer after failure of combination chemotherapy
`for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have
`included an anthracycline unless clinically contraindicated.
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`We completed our review of this application, as amended. This application is approved, effective on
`the date of this letter, for use as recommended in the agreed-upon labeling text.
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`Within 21 days of the date of this letter, submit content of labeling [21 CFR 314.50(l)] in structured
`product labeling (SPL) format, as described at http://www.fda.gov/oc/datacouncil/spl.html, that is
`identical in content to the enclosed labeling. Upon receipt and verification, we will transmit that
`version to the National Library of Medicine for public dissemination.
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`The final printed labeling (FPL) for this supplement S-010 must be identical to the enclosed labeling
`(text for the package insert, and text for the patient package insert) submitted February 9, 2007. Please
`note that your final printed labeling submitted January 20, 2005, for this NDA has been superseded but
`will be retained in the file.
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 21-660/S-010.” Approval of this submission by FDA
`is not required before the labeling is used.
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`We remind you of your postmarketing study commitment in your submission dated January 4, 2004,
`listed below.
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`

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`NDA 21-660/S-010
`Page 2
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`2.
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`You should evaluate ABRAXANE® safety and pharmacokinetics in subjects with
`hepatic impairment, to allow the determination of dosing adjustment for this population.
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`Protocol Submission: April 2005
`Study Start: November/December 2005
`Final Report Submission: December 2006
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`Per your submission of December 5, 2006, we understand that the final report submission for this
`postmarketing study commitment will be delayed until November 2007. This is acceptable.
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`We have reviewed your submissions dated June 28 and August 12, 2005, and conclude that the
`following commitment from the January 7, 2005, approval letter was fulfilled.
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`1.
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`Survival data and analysis results should be submitted from randomized study CA012-0
`when 80% of the patients have died. Data should be available for submission
`approximately June 2005.
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`Submit clinical protocols to your IND for this product. Submit nonclinical and chemistry,
`manufacturing, and controls protocols and all study final reports to this NDA. In addition, under 21
`CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii), you should include a status summary of each
`commitment in your annual report to this NDA. The status summary should include expected
`summary completion and final report submission dates, any changes in plans since the last annual
`report, and, for clinical studies, number of patients entered into each study. All submissions, including
`supplements, relating to these postmarketing study commitments must be prominently labeled
`“Postmarketing Study Commitment Protocol”, “Postmarketing Study Commitment Final
`Report”, or “Postmarketing Study Commitment Correspondence.”
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send copies of
`both the promotional materials and the package insert directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-660/S-010
`Page 3
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`If you have any questions, please call Frank Cross, Project Manager, at (301) 796-0876.
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`Sincerely,
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`{See appended electronic signature page}
`
`Ann Farrell, M.D.
`Acting Deputy Division Director
`Division of Drug Oncology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
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`Enclosure
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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/
`---------------------
`Ann Farrell
`2/15/2007 03:29:58 PM
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