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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/S-022
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`Abraxis BioScience, Inc.
`Attention: Monica Batra
`Sr. Regulatory Scientist
`2730 Wilshire Blvd., Suite 500
`Santa Monica, CA 90403
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`Dear Ms. Batra:
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`Please refer to your supplemental new drug application dated July 31, 2008, and received August 1,
`2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Abraxane
`(paclitaxel protein-bound particles for injectable suspension) (albumin bound), 100 milligram vial.
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`We also acknowledge receipt of your submission dated May 29 and electronic mail correspondence of
`June 18, 2009.
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`This supplemental new drug application provides for the completed final report for CA037, A Phase I
`Study to Evaluate the Safety and Pharmacokinetics of ABI-007 in Patients with Advanced Solid
`Tumors and Hepatic Dysfunction to fulfill the January 7, 2005 postmarketing study commitment 2
`with labeling changes to include dosing adjustments for hepatically impaired patients as well as
`additional labeling changes proposed for consistency with company’s core data sheet and global
`labeling.
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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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` As soon as possible, but no later than 14 days from the date of this letter, please submit the content of
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`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 to the enclosed labeling (text for the
`package insert, text for the patient package insert). 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 NDA 21-660.”
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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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`NDA 21-660/S-022
`Page 2
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` MEDWATCH
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`Food and Drug Administration
`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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 Janet Jamison, Acting Safety Regulatory Project Manager, at (301) 796­
`2313.
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`Sincerely,
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` {See appended electronic signature page}
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`Robert Justice, MD, MS
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` Director
`Division of Drug Oncology Products
`Office of Oncology 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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`---------------------
`Amna Ibrahim
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`6/26/2009 12:37:28 PM
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`For Dr Robert Justice
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`