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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021344/S-039
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` AstraZeneca Pharmaceuticals LP
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` Attention: Michele Shannon, PhD
` Director, Global Regulatory Affairs
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` One MedImmune Way
` Gaithersburg, MD 20878
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`Dear Dr. Shannon:
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`Please refer to your Supplemental New Drug Application (sNDA) dated February 12, 2019,
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`received February 12, 2019, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Faslodex® (fulvestrant) Injection, 250 mg/5 mL.
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`This Prior Approval supplemental new drug application provides for the following changes in
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`response to the agency’s Supplement Request letter dated January 15, 2019:
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`1. Remove “Single-Patient Use Only” from the carton label;
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`2. Add “Single-dose prefilled syringe” to all labeling (package insert sections 3 and 16,
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`carton label, and container label); and
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`3. Add “Discard unused portion” to the package insert section 16 and carton label.
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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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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the Prescribing Information and
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`Patient Package Insert), with the addition of any labeling changes in pending “Changes Being
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Reference ID: 4435906
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` NDA 021344/S-039
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` Page 2
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` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that include labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
` with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes. To
` facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
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` changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
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` CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed carton and
`container labeling as soon as they are available, but no more than 30 days after they are printed.
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`Please submit these labeling electronically according to the guidance for industry titled
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`Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
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`Product Applications and Related Submissions Using the eCTD Specifications (April 2018,
`Revision 5). For administrative purposes, designate this submission “Final Printed Carton and
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`Container Labeling for approved NDA 021344/S-039.” Approval of this submission by FDA
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`is not required before the labeling is used.
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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
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`active ingredients (which includes new salts and new fixed combinations), new indications, new
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`dosage forms, new dosing regimens, or new routes of administration are required to contain an
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`assessment of the safety and effectiveness of the product for the claimed indication in pediatric
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`patients unless this requirement is waived, deferred, or inapplicable.
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`We are waiving the pediatric studies requirement for this application because necessary studies
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`are impossible or highly impracticable in children.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 4435906
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` NDA 021344/S-039
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` Page 3
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` If you have any questions, contact Rajesh Venugopal, Senior Regulatory Project Manager, at
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` (301) 796-4730.
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`Sincerely,
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`{See appended electronic signature page}
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`Laleh Amiri-Kordestani, MD
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`Supervisory Associate Director
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`Division of Oncology Products 1
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`Office of Hematology and Oncology Products
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`Content of Labeling
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`Prescribing Information
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`Patient Package Insert
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`Carton and Container Labeling
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`Reference ID: 4435906
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
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`LALEH AMIRI KORDESTANI
`05/20/2019 01:34:26 PM
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`Reference ID: 4435906
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`(
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