`NDA 203565/S-013
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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, OH 43054
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`SUPPLEMENT APPROVAL
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`
` Dear Ms. Ernst:
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` Please refer to your supplemental new drug application (sNDA) dated and received
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`
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` June 26, 2020, and your amendment, submitted under section 505(b) of the Federal
` Food, Drug, and Cosmetic Act (FDCA) for Injectafer (ferric caboxymaltose) 50 mg/mL
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` for Injection.
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` We also refer to our letter dated June 2, 2020, notifying you, under Section 505(o)(4) of
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`the FDCA, of new safety information that we believe should be included in the labeling
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` for parenteral iron products. This information pertains to the risk of fetal adverse
` reactions including fetal bradycardia associated with maternal hypersensitivity reactions
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` following parenteral iron administration.
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` This supplemental new drug application provides for revisions to Section 8 of the
` approved labeling for Injectafer (ferric caboxymaltose), consistent with our June 2, 2020
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`
`
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` letter.
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` APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`
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`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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`
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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
`Prescribing Information, Patient Package Insert), with the addition of any labeling
`changes in pending “Changes Being Effected”
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4668211
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` NDA 203565/S-013
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` Page 2
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`(CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 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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`
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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
`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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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`
` by a Form FDA 2253, at the time of initial dissemination or publication
` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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` Instructions for completing the form can be found at FDA.gov.5
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`
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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 Lori Anne Wachter, RN, BSN, RAC, Regulatory Project
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`
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` Manager for Safety (Acting), at 301 796-3975.
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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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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`
`
`Silver Spring, MD 20993
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`
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`www.fda.gov
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`Reference ID: 4668211
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`NDA 203565/S-013
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`Page 3
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Rosanna Setse, M.D., Ph.D.
`
`
`Acting Deputy Director for Safety
`
`Division of Non-Malignant Hematology Products
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`
`Office of Cardiology, Hematology,
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`Endocrinology,
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`and Nephrology Center for Drug Evaluation and
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`Research
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`
`
` U.S. Food and Drug Administration
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`
` Silver Spring, MD 20993
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`
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` www.fda.gov
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`Reference ID: 4668211
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`
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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/
`------------------------------------------------------------
`
`ROSANNA W SETSE
`09/11/2020 07:42:21 AM
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`Reference ID: 4668211
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`