SUPPLEMENT APPROVAL
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`NDA 203565/S-009
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`American Regent, Inc.
`Attention: Elizabeth Ernst
`Global Executive Director of Regulatory Affairs
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`5 Ramsey Road
`Shirley, New York 11967
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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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`August 16, 2019, 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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`750 mg Iron/15 mL.
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`This Prior Approval supplemental new drug application provides for revisions to the
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`following sections of the approved labeling:
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`1. In section 1 Indications and Usage, a minor editorial change to add the word
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`“or”
`2. Revised section 2 Dosage and Administration to include new subsections 2.1
`Recommended Dosage and relevant language, 2.2 Preparation and
`Administration and relevant language, 2.3 Repeat Treatment Monitoring
`Safety Assessment and relevant language
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`3. In section 5 Warnings and Precautions added a new subsection 5.2
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`Symptomatic Hypophosphatemia with relevant language
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`4. In section 6 Adverse Reactions added a new bullet titled hypophosphatemia
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`[Post-marketing Experience (6.2)]
`5. Revised language in section 6.2 Post-marketing Experience
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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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`labeling.
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`Reference ID: 4563426
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`NDA 203565/S-009
`Page 2
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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, 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
`reportable changes not included in the 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 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
`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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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4) to the
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`address above, by fax to 301-847-8444, or electronically in eCTD format. For more
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`information about submitting promotional materials in eCTD format, see the draft
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`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.
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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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`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
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4563426
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`NDA 203565/S-009
`Page 3
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`If you have any questions, call Ms. June Germain, Safety Regulatory Project Manager,
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`at 301-796-4024.
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`Sincerely,
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`{See appended electronic signature page}
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`Rosanna Setse, MD, PhD
`Acting Deputy Director Safety
`Division of Hematology Products
`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
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`Prescribing Information
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`Patient Package Insert
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4563426
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