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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-660/S013
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` Abraxis Bioscience, Inc.
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`Attention: Aleece C. Nolasco
`Regulatory Scientist
`4503 Glencoe Avenue
`Marina Del Ray, CA 90292
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`Dear Ms. Nolasco:
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`Please refer to your supplemental new drug application S013, dated May 24, 2007 and received May
`25, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Abraxane®
`(paclitaxel) for injectable suspension.
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`We acknowledge receipt of your submission dated May 24, 2007 and to the related Addendum 1 to the
`Periodic Adverse Drug Experience Report 2007, dated May 24, 2007.
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`This “Changes Being Effected” supplemental new drug application provides for an addition to the
`ADVERSE EVENT EXPERIENCE BY BODY SYSTEM section of the labeling (package insert) with
`the following text:
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`“During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have
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`been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting
`hypersensitivity to paclitaxel injection or human albumin has not been studied. Patients who
`experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with
`the drug.”
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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 enclosed 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 text/submitted labeling dated May 24, 2007. Upon receipt,
`we will transmit that version to the National Library of Medicine for public dissemination. For
`administrative purposes, please designate this submission “SPL for approved supplement NDA 21-
`660/S013”.
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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
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`the following address:
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`

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`NDA 21-660/S013
`Page 2
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`MEDWATCH
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`Food and Drug Administration
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`5515 Security Lane
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`HFD-001, Suite 5100
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`Rockville, MD 20852
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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, please call Carl Huntley, Regulatory Project Manager, at (301) 796-1372.
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`Sincerely,
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` {See appended electronic signature page}
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`Robert Justice, M.D.
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` 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/
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`---------------------
`Robert Justice
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`7/1/2008 05:46:05 PM
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