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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021344/S-007/S-012
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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
`Attention: Nicholas J. Troise
`Regulatory Affairs Director
`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 (sNDA) dated December 1, 2005 and
`November 12, 2009, received December 2, 2005 and November 13, 2009, submitted under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Faslodex®
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`(fulvestrant) Solution for Injection.
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`We acknowledge receipt of your amendments dated January 24, 2006, September 28, 2006, April
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`25, 2007, March 4, 2010, March 24, 2010 and May 14, 2010. This supplement provides for
`revisions regarding Hepatic Impairment to the following sections of the label: Dosage and
`Administration, Warnings & Precautions, Special Populations and Clinical Pharmacology.
`These revisions are based on results from trial 9238IL/0063.
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`We have completed our review of supplement 007, 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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`We also acknowledge receipt of your amendments dated November 16, 2009, December 22,
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`2009, December 23, 2009, January 21, 2010, February 1, 2010, March 15, 2010, April 19, 2010,
`May 10, 2010, May 12, 2010, May 21, 2010, June 25, 2010, July 7, 2010, August 6, 2010,
`August 12, 2010, August 13, 2010, August 25, 2010, August 26, 2010, September 1, 2010,
`September 7, 2010 and September 8, 2010. This sNDA provides for changing the dosage of
`Faslodex® from 250 mg to 500 mg.
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`We have completed our review of supplement 012, 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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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
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`Page 2
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`identical to the enclosed labeling (text for the package insert, text for the patient package insert)
`and include the labeling changes proposed in any pending “Changes Being Effected” (CBE)
`supplements. Information on submitting SPL files using eLIST may be found in the guidance for
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`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
`pending “Changes Being Effected” (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.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the enclosed carton and
`immediate container labels submitted on September 1, 2010, as soon as they are available, but no
`more than 30 days after they are printed.
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`Please submit these labels electronically according to the guidance for industry titled “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 “Product
`Correspondence – Final Printed Carton and Container Labels for approved NDA
`021344/012.” Approval of this submission by FDA 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
`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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`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable.
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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
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`Center for Drug Evaluation and Research
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`Division of Drug Marketing, Advertising, and Communications
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`5901-B Ammendale Road
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`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.(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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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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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 Alberta Davis-Warren, Regulatory Project Manager, at
`(301) 796-3908.
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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(S):
`Content of Labeling
`Carton and Container Labeling
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`Application
`Type/Number
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`NDA-21344
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`Submission
`Type/Number
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`SUPPL-12
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`NDA-21344
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`SUPPL-7
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`Submitter Name
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`Product Name
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`------------------------------------------
`--------------------
`FASLODEX
`ASTRAZENECA
`PHARMACEUTICA (FULVESTRANT)250MG/5ML
`LS LP
`INJ
`ASTRAZENECA
`FASLODEX
`PHARMACEUTICA (FULVESTRANT)250MG/5ML
`LS LP
`INJ
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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
`09/09/2010
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