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`A D M I N I STRATION
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` NDA 203565/S-019
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` APPROVAL LETTER
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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
` New Albany, OH 43054
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` Dear Ms. Ernst:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received
` October 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 addition of a
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` injection) at American Regent’s
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` of Injectafer® (ferric carboxymaltose
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` new 2 mL fill
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`size
` Hilliard, OH
` (FEI# 3005761472).
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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.
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` Content of labeling must be identical to the enclosed labeling (text for the prescribing
` 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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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
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` nces/UCM072392.pdf.
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` The SPL will be accessible via publicly available labeling repositories.
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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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`(b) (4)
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` NDA 203565/S-019
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` Page 2
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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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` CARTON AND CONTAINER LABELS
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` Submit final printed carton and container labels that are identical to enclosed carton and
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` container labels, as soon as they are available, but no more than 30 days after they are
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` printed. Please submit these labels electronically according to the guidance for industry
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` Providing Regulatory Submissions in Electronic Format – Certain Human
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` Pharmaceutical Product Applications and Related Submissions Using the eCTD
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` Specifications. For administrative purposes, designate this submission “Product
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` Correspondence – Final Printed Carton and Container Labels for approved NDA
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`203565/S-019.” Approval of this submission by FDA is not required before the labeling
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` We remind you that you must comply with reporting requirements for an approved NDA
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` set forth under 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
` Division of Post-Marketing Activities I
` Office of Lifecycle Drug Products
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` Office of Pharmaceutical Quality
` Center for Drug Evaluation and Research
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` Enclosure(s):
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` Content of Labeling
` Carton and Container 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: 2/04/2022 03:13:12PM
`GUID: 502d0913000029f375128b0de8c50020
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