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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 203565/S-008
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Luitpold Pharmaceuticals, Inc.
`Attention: Raenel Gibson
`Regulatory Affairs Director
`6610 New Albany Road East
`New Albany, OH 43054
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`Dear Ms. Gibson:
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`Please refer to your Supplemental New Drug Application (sNDA) dated May 10, 2018, received
`May 10, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for INJECTAFER® (ferric carboxymaltose injection), 750 mg Iron/15
`mL.
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`This “Changes Being Effected” supplemental new drug application provides for the following
`changes:
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`1. The removal of the DRUG INTERACTIONS section from the Full Prescribing
`Information: Content to align with the Full Prescribing Information.
`2. “Single-Use” has been changed to “Single-Dose” throughout the Prescribing Information.
`3. A correction of the age range of patients enrolled to Trial 1VIT09030 in subsection 14.2
`(Trial 2: Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic
`Kidney Disease) of the Prescribing Information.
`4. The following correction of a grammatical error in subsection 12.3 (Pharmacodynamics)
`of the Prescribing Information: “…61% to 84% after..” to “…61% to 84% at…”.
`5. The following correction of a grammatical error in subsection 6.2 (Post-marketing
`Experience) of the Prescribing Information: “pruritis” to “pruritus”.
`6. Updated manufacturer information at end of the Patient Package Insert.
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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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`Reference ID: 4339971
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`NDA 203565/S-008
`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 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
`of labeling must be identical to the enclosed labeling (text for the Prescribing Information and
`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. If the content of labeling in SPL format initially submitted with this CBE-0 labeling
`supplement is identical to the attached approved labeling, an additional submission of content of
`labeling in SPL format is not required.
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`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 Microsoft Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes. To
`facilitate review of your submission(s), 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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`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}
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`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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`Reference ID: 4339971
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`NDA 203565/S-008
`Page 3
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`ENCLOSURES:
`Content of Labeling
`Prescribing Information
`Patient Package Insert
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`Reference ID: 4339971
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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/
`------------------------------------------------------------
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`ALBERT B DEISSEROTH
`10/25/2018
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`Reference ID: 4339971
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`(
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