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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 21-344/S-001
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`AstraZeneca Pharmaceuticals LP
`Attention: Kathleen R. Gans-Brangs, Ph.D.
` Regulatory Affairs Director
`1800 Concord Pike
`P.O. Box 8355
`Wilmington, DE 19803-8355
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`Dear Dr. Gans-Brangs:
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`Please refer to your supplemental new drug application dated February 21, 2003, received
`February 24, 2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`FASLODEX (fulvestrant) Injection.
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`We acknowledge receipt of your submission dated November 19, 2003.
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`This supplemental new drug application provides the results of a study of the effect of ketoconazole
`treatment on the pharmacokinetics of fulvestrant following intravenous dosing of fulvestrant. Also,
`revised labeling was submitted.
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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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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert).
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`Please submit the FPL electronically 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, in no case more than 30 days after it is printed. Please individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, this submission
`should be designated "FPL for approved supplement NDA 21-344/S-001”. Approval of this
`submission by FDA is not required before the labeling is used.
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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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`MEDWATCH, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`NDA 21-344/S-001
`Page 2
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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 Amy Baird, Project Manager, at (301) 594-5779.
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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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`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.
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` /s/
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`Richard Pazdur
`12/24/03 12:02:15 PM
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