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`A D M I N I STRATION
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` NDA 203565/S-017
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`SUPPLEMENT APPROVAL
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` American Regent, Inc
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` Attention: Elizabeth Ernst
` Global Executive Director of Regulatory Affairs
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` 6610 New Albany Road East
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` New Albany, NY 43054
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` Dear Ms. Ernst:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received
` February 4, 2021, and your amendments, submitted under section 505(b) of the Federal
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` Food, Drug, and Cosmetic Act (FDCA) for Injectafer (ferric carboxymaltose injection).
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` This Prior Approval supplemental new drug application provides for the following
` changes to the section 11 “Description” of the prescribing information:
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` • Changing the chemical name of the drug substance from “polynuclear iron (III)
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`hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-
`tetrahydroxy-hexanoate” to “polynuclear iron (III) hydroxide 4(R)-(poly-(1→4)-O-
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`α-D-glucopyranosyl)-oxy2(R),3(R),5(R),6-tetrahydroxy-hexanoate”.
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`• Replacing the old chemical structure with the new chemical structure.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is
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`approved, effective on the date of this letter, for use as recommended in the enclosed
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`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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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the prescribing
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`information) 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
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`enclosed labeling.
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`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
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 203565/S-017
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` Page 2
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
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`The SPL will be accessible via 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 MS Word format,
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`that includes the changes approved in this supplemental application, as well as annual
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`reportable changes, and annotate each change. To facilitate review of your submission,
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`provide a highlighted or marked-up copy that shows all changes, as well as a clean
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`Microsoft Word version. The marked-up copy should provide appropriate annotations,
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`including supplement number(s) and annual report date(s).
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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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`If you have any questions, call Chelsea Bostic, Regulatory Business Process Manager,
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`at (301) 796 - 8862.
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`Sincerely,
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`{See appended electronic signature page}
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`Ramesh Raghavachari, PhD
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`Chief, Branch I
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosure(s):
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`Content of Labeling
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Ramesh
`Raghavachari
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`Digitally signed by Ramesh Raghavachari
`Date: 8/04/2021 04:26:30PM
`GUID: 502d0913000029f375128b0de8c50020
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`