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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA 203565/S-005
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING
`REQUIREMENT
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`Luitpold Pharmaceuticals, Inc.
`Attention: Marsha Simon
`Director, Regulatory Affairs
`800 Adams Avenue
`Norristown, PA 19403
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`Dear Ms. Simon:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated July 28, 2017, received
`July 28, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for INJECTAFER (ferric carboxymaltose injection), 750 mg/15 mL.
`
`This Prior Approval supplemental new drug application provides for updates to the United States
`Prescribing Information (USPI) to adhere to the Pregnancy and Lactation Labeling Final Rule,
`removal of section 7 DRUG INTERACTIONS, and other minor formatting changes. The Patient
`Information label was also updated to be consistent with the USPI. In addition, this action
`includes fulfillment of Post Marketing Requirement 2064-1 based upon the final clinical study
`report submitted for clinical study 1VITI3036 entitled, “A Multi-center, Open-label, Single Arm
`Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous
`Ferric Carboxymaltose in Pediatric Subjects 1-17 years old with Iron Deficiency Anemia
`(IDA).”
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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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 content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`Reference ID: 4212697
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`

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`NDA 203565/S-005
`Page 2
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert), with the addition of any labeling changes in pending “Changes Being
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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 action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a 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 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 new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`FULFILLMENT OF POSTMARKETING REQUIREMENT(S)/COMMITMENT(S)
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`We have received your submission dated July 28, 2017, containing the final report for the
`following postmarketing requirement listed in the July 25, 2013 approval letter.
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`PMR 2064-1 Identify an optimal dose of INJECTAFER (ferric carboxymaltose injection) for
`the pediatric patient population. Conduct one or more pharmacokinetic (PK) and
`pharmacodynamic (PD) trials in pediatric patients aged 1 to <17 years with iron
`deficiency anemia sufficient to justify and to characterize the dose to be tested in
`a confirmatory clinical trial of safety and efficacy. Identify the most relevant PD
`endpoints to measure.
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`Final Protocol Submission: 07/2014
`Trial Completion:
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`07/2016
`Final Report Submission:
`07/2017
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`Reference ID: 4212697
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`NDA 203565/S-005
`Page 3
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`We have reviewed your submission and conclude that the above requirement was fulfilled.
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`We remind you that there is a postmarketing requirement listed in the July 25, 2013 approval
`letter that is still open.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Thomas Iype, Regulatory Project Manager, at (240) 402-6861.
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`Sincerely,
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`{See appended electronic signature page}
`
`Albert Deisseroth, MD, PhD
`Supervisory Associate Division Director
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`
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`Reference ID: 4212697
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`ALBERT B DEISSEROTH
`01/26/2018
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`Reference ID: 4212697
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`