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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
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`American BioScience, Inc.
`Attention: Mitchall G. Clark
`Vice President, Regulatory Affairs
`2730 Wilshire Boulevard, Suite 110
`Santa Monica, CA 90403
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`Dear Mr. Clark:
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`Please refer to your new drug application (NDA) dated March 4, 2004, received March 8, 2004,
`pursuant to section 505(b)(2) 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 30, July 21, and August 21, 2003; February 4
`and 27; March 4, 15, 18, and 19; April 2 and 8; May 7; June 21; July 7, 22, 23, 26, 28, and 30; August
`12 and 25; September 10 and 11; October 12; December 21, 22, and 29, 2004; and January 4, 2005.
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`This new drug application provides for the use of ABRAXANE™ for Injectable Suspension (paclitaxel
`protein-bound particles for injectable suspension) for 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 anthracyline unless clinically contraindicated.
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`We completed our review of this application, as amended. It is approved, effective on the date of this
`letter, for use as recommended in the agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert,
`text for the patient package insert and carton labels). Marketing the product with FPL that is not
`identical to the approved labeling text may render the product misbranded and an unapproved new
`drug.
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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 NDA 21-660.” Approval of this submission by FDA is not required
`before the labeling is used.
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`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are
`waiving the pediatric study requirement for this application.
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`NDA 21-660
`Page 2
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`We remind you of your postmarketing study commitments in your submission dated January 4, 2004.
`These commitments are listed below.
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`1. 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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`2. 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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`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 Protocol”, “Postmarketing Study Final Report”, or “Postmarketing Study
`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 one copy to
`the Division of Oncology Drug Products and two copies of both the promotional materials and the
`package inserts directly to:
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`Please submit one market package of the drug product when it is available.
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`We have not completed validation of the regulatory methods. However, we expect your continued
`cooperation to resolve any problems that may be identified.
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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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`Division of Drug Marketing, Advertising,
`and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, MD 20857
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`Protocol Submission: April 2005
`Study Start: November/December 2005
`Final Report Submission: December 2006
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`NDA 21-660
`Page 3
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`If you have any questions, call Sheila Ryan, Pharm.D., Regulatory Project Manager, at (301) 594-
`5771.
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`Enclosure
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`Sincerely,
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`{See appended electronic signature page}
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`Richard Pazdur, M.D.
`Director
`Division of Oncology Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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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/
`---------------------
`Grant Williams
`1/7/05 12:04:29 PM
`Signed for Dr. Pazdur
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