`NDA 021344/S-044
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`SUPPLEMENT APPROVAL
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` AstraZeneca Pharmaceuticals LP
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` Attention: Rocelyn DelCarmen
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` Regulatory Affairs Director
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` One MedImmune Way
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` Gaithersburg, MD 20878
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` Dear Ms. DelCarmen:
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` Please refer to your supplemental new drug application (sNDA) dated August 7, 2020,
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` received August 7, 2020, submitted under section 505(b) of the Federal Food, Drug,
` and Cosmetic Act (FDCA) for Faslodex® (fulvestrant) Injetion, 250 mg/5 mL.
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`This “Changes Being Effected” supplemental new drug application provides for an
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`update to the currently approved label to add Figure 14: Kaplan-Meier plot of Overall
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`Survival – MONALEESA-3 (Intent-to-Treat Population).
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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` Prescribing Information and Patient Package Insert), with the addition of any labeling
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` changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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` reportable changes not included in the enclosed labeling. If the content of labeling in
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` SPL format initially submitted with this CBE-0 labeling supplement is identical to the
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` attached approved labeling, an additional submission of content of labeling in SPL
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` format is not required.
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` Information on submitting SPL files using eList may be found in the guidance for
` industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4733430
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` NDA 021344/S-044
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` Page 2
` 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
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` changes for this NDA, including CBE supplements for which FDA has not yet issued an
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` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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` format, that includes the changes approved in this supplemental application, as well as
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` annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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` Word version. The marked-up copy should provide appropriate annotations, including
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` supplement number(s) and annual report date(s).
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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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`We are waiving the pediatric studies requirement for this application because necessary
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`studies are impossible or highly impracticable.
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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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` U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4733430
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`Sincerely,
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`{See appended electronic signature page}
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`Amna Ibrahim, MD
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`Deputy Director
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`Division of Oncology 1
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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` NDA 021344/S-044
` Page 3
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` If you have any questions, contact Kelly Chiang, Regulatory Project Manager, at
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` Duyen.Mach@fda.hhs.gov or 301-796-5822.
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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` U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4733430
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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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`AMNA IBRAHIM
`01/19/2021 03:00:12 PM
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`Reference ID: 4733430
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