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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021344/S-031
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`AstraZeneca Pharmaceuticals LP
`Attention: Jamie L. Austin, PhD, RAC
`Regulatory Affairs Director
`200 Orchard Ridge Drive
`Gaithersburg, MD 20878
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`Dear Dr. Austin:
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`Please refer to your Supplemental New Drug Application (sNDA) dated August 30, 2016,
`received August 30, 2016, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for FASLODEX® (fulvestrant) Solution for Injection, 250 mg/5 ml.
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`This “Changes Being Effected” supplemental new drug application proposes updates to the
`instructions and pictures on the carton and container labeling to match the Full Prescribing
`Information that was approved for NDA 021344 Supplement 027.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
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` 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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`We acknowledge your August 30, 2016, and October 25, 2016 submissions containing final
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`printed carton and container labels.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`Reference ID: 4004542
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`NDA 021344/S-031
`Page 2
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf).
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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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`Reference ID: 4004542
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`NDA 021344/S-031
`Page 3
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`If you have any questions, call Charlene Wheeler, MSHS, Senior Regulatory Project Manager, at
`(301) 796-1141.
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`Sincerely,
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`{See appended electronic signature page}
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`Geoffrey Kim, MD
`Director
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`Division of Oncology Products 1
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Carton and Container Labeling
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`Reference ID: 4004542
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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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`CHARLENE N WHEELER
`10/26/2016
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`GEOFFREY S KIM
`10/26/2016
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`Reference ID: 4004542
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`(
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