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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021344/S-033
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Astra Zeneca
`Attention: Jamie L. Austin, Ph.D., RAC
`Regulatory Affairs Director
`1800 Concord Pike
`Wilmington, DE 19803
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`Dear Dr. Austin:
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`Please refer to your Supplemental New Drug Application (sNDA) dated October 10, 2016,
`received October 10, 2016, and your amendment dated November 7, 2016, received on
`November 7, 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Faslodex (fulvestrant) Injection.
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`This Changes Being Effected supplemental new drug application provides for updated carton
`labeling to match the Full Prescribing Information approved under NDA 021344/S-029 on
`July 12, 2016.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to carton and
`immediate-container labels submitted on November 4, 2016 as soon as they are available, but no
`more than 30 days after they are printed. Please submit these labels electronically according to
`the guidance for industry Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies individually
`mounted on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “Final Printed Carton and Container Labels for approved NDA 021344/S-033.”
`Approval of this submission by FDA is not required before the labeling is used.
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`Reference ID: 4045639
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`NDA 021344/S-033
`Page 2
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` REPORTING REQUIREMENTS
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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 Pamela Balcazar, Regulatory Project Manager, at (240) 402-4203.
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, MD
`Deputy Director
`Division of Hematology and Oncology Products 1
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Carton and Container Labeling
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`Reference ID: 4045639
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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
`01/24/2017
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`Reference ID: 4045639
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`(
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