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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-004
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`AstraZeneca Pharmaceuticals LP
`Attention: Debra N. Shiozawa, Ph.D.
`Regulatory Affairs Associate Director
`1800 Concord Pike
`P.O. Box 8355
`Wilmington, DE 19803-8355
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`Dear Dr. Shiozawa:
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`Please refer to your supplemental new drug application dated February 1, 2005, received February 2,
`2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for FASLODEX7
`(fulvestrant) Injection.
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`This “Changes Being Effected” supplemental new drug application provides for updated survival
`language in the CLINICAL PHARMACOLOGY-Clinical Studies section. Also, the ADVERSE
`REACTIONS section has been updated to include hypersensitivity reactions.
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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 attached 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 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 21-344/S-004.” 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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`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, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
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`NDA 21-344/S-004
`Page 2
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`If you have any questions, call Amy Baird, Consumer Safety Officer, at (301) 594-5779.
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`Sincerely,
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`{See appended electronic signature page}
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`Robert L. Justice, M.D.
`Acting 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.
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` /s/
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`Robert Justice
`8/2/05 05:47:19 PM
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