`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 21344/S-037
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
` AstraZeneca Pharmaceuticals LP
`
`
`
` Attention: Michele Shannon, PhD
` Director, Global Regulatory Affairs
`
`
`
` One Medimmune Way
` Gaithersburg, MD 20878
`
`
`
`
`
`Dear Dr. Shannon:
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated September 14, 2018,
`
`
`
`received September 14, 2018 submitted under section 505(b) of the Federal Food, Drug, and
` Cosmetic Act (FDCA) for Faslodex® (fulvestrant) Injection 250 mg/5 mL.
`
`
`
`
`
`
`
`
`
` This Prior Approval supplemental new drug application provides for adding an additional
` indication for the treatment of HR-positive, HER2-negative advanced or metastatic breast
`
`
`
`
`
`
` cancer in postmenopausal women, in combination with ribociclib, as initial endocrine based
`
` therapy or following disease progression on endocrine therapy.
`
` APPROVAL & LABELING
`
`
`
`
`
`
`We have completed our review of this supplemental application. It is approved, effective on the
`
`
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`
`CONTENT OF LABELING
`
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`
`
`
`
`
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`
`automated drug registration and listing system (eLIST), as described at
`
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`
`of labeling must be identical to the enclosed labeling (text for the Prescribing Information, and
`
`
`
`text for Patient Package Insert), with the addition of any labeling changes in pending “Changes
`
`Being Effected” (CBE) supplements, as well as annual reportable changes not included in the
`
`enclosed labeling.
`
`
`
`
`
`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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`
`CM072392.pdf.
`
`Reference ID: 4401608
`
`
`
`
`
`
`
` NDA 21344/S-037
`
`
` Page 2
`
`
`
` The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling changes
`
`
`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
`
`
`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
`
`
`
`
`
`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).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`active ingredients (which includes new salts and new fixed combinations), 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 in pediatric
`
`patients unless this requirement is waived, deferred, or inapplicable.
`
`
`We are waiving the pediatric study requirement for this application because necessary studies are
`
`impossible or highly impractical.
`
`
`PROMOTIONAL MATERIALS
`
`
`
`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 Prescribing Information to:
`
`
`
`
`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
`
`
`
`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).
`
`
`
`You must submit final promotional materials and Prescribing Information, accompanied by a
`
`
`
`
`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)].
`
`Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`
`Reference ID: 4401608
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Laleh Amiri-Kordestani, MD
`
`
`Supervisory Associate Director
`
`Division of Oncology Products 1
`
`Office of Hematology and Oncology Products
`
`Center for Drug Evaluation and Research
`
` NDA 21344/S-037
`
`
` Page 3
`
`
` 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.
`
`
`REPORTING REQUIREMENTS
`
`
` We remind you that you must comply with reporting requirements for an approved NDA
`
`
`
` (21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`If you have any questions, call Fatima Rizvi, PharmD, Regulatory Project Manager, at
`
`(240) 402-7426.
`
`
`
`
`
`
`ENCLOSURE(S):
`
`
`Content of Labeling
`
`
`
`
`
`Reference ID: 4401608
`
`
`
`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/
`------------------------------------------------------------
`
`LALEH AMIRI KORDESTANI
`03/11/2019 09:52:16 AM
`
`Reference ID: 4401608
`
`