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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021344/S-019/S-020
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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: Nicholas J. Troise
`1800 Concord Pike
`P.O. Box 8355
`Wilmington DE 19803-8355
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`Dear Mr. Troise:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated May 10, and
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`June 28, 2012 received May 10 and June 28, 2012, respectively, submitted under section 505(b)
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`of the Federal Food, Drug, and Cosmetic Act (FDCA) for Faslodex® (fulvestrant) Injection,
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`250 mg/5 mL.
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`We acknowledge receipt of your amendments dated May 15, July 24, October 12, and
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`October 19, 2012 (S-019).
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`We also acknowledge receipt of your amendments dated July 13 and July 25, 2012 (S-020).
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`S-019: “Changed Being Effective” supplemental new drug application S-019 provides an update
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`for nonclinical toxicology for post-marketing safety data and information from a mouse
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`carcinogenicity study (VKS0539 (0118CM).
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`S-020: “Prior Approval” efficacy supplemental new drug application S-020 provides for updated
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`results of overall survival data from a Randomized, Double-Blind, Parallel-group, Multicentre,
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`Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (Faslodex®) 500 mg
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`with Fulvestrant (Faslodex®) 250 mg in Postmenopausal Women with Oestrogen Receptor
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`Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy
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`(D6997C00002), also known as the 'CONFIRM' study.
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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
`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 package insert and Medication
`Guide), 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.
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`Reference ID: 3215285
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`NDA 021344/S-019/S-020
`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
`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 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 MS Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, 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).
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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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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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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
`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Division of Drug Marketing, Advertising, and Communications
`(DDMAC), 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: 3215285
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`If you have any questions, call Techiya Toaff, Regulatory Project Manager, at (301) 796-4256.
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`NDA 021344/S-019/S-020
`Page 3
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, M.D.
`Deputy Director
`Division of Drug Oncology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3215285
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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
`11/09/2012
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`Reference ID: 3215285
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