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`i 4 DEPARTMENTOFHEALTHANDHUMAN SERVICES
`"‘>Q
`
`NDA 21462/S-052
`
`Eli Lilly and Company
`Attention: Paul Orth, PharmD
`
`Manager, Global Regulatory Affairs-US
`Lilly Corporate Center, Drop Code 2543
`Indianapolis, IN 46285
`
`Dear Dr. Orth:
`
`Food and Drug Administration
`Silver Spring, MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received October 20,
`2017, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Alimta® (pemetrexed for injection).
`
`This Prior Approval supplemental new drug application provides for revisions to the carton and
`container labels for the drug product, to change the term “Single-Use Vial” to “Single -Dose Vial”.
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`CONTENT OF LABELING
`
`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(1)] in structured product labeling (SPL) format using the FDA automated
`drug registration and listing system (eLIST), as described at
`hfipzflwwwfda.gov/ForIndusfl/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (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 Standardfor Content ofLabeling Technical Qs and As at
`hm; ://www.fda . gov/downloads/DrugsGuidanceComplianceRegulatoggInformation/Guidances/U
`CM072392 .pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`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
`
`
`
`NDA 21462/S-052
`Page 2
`
`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).
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to enclosed carton and
`immediate container labels, as soon as they are available, but no more than 30 days after they are
`printed. Please submit these labels electronically according to the guidance for industry Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and
`Related Submissions Using the eCTD Specifications (May 2015, Revision 3). For administrative
`purposes, designate this submission “Product Correspondence – Final Printed Carton and
`Container Labels for approved NDA 21462/S-052.” Approval of this submission by FDA is not
`required before the labeling is used.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`If you have any questions, call Adijat Abass-Fasuyi, Regulatory Business Process Manager, at
`(301) 796 - 3609.
`
`
`
`Enclosure:
`Carton and Container Labeling
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Ramesh Raghavachari, Ph.D.
`Chief, Branch I
`Division of Post-Marketing Activities I
`Office of Lifecycle Drug Products
`Office of Pharmaceutical Quality
`Center for Drug Evaluation and Research
`
`
`
`
`
`Ramesh
`Raghavachari
`
`Digitally signed by Ramesh Raghavachari
`Date: 4/17/2018 02:27:17PM
`GUID: 502d0913000029f375128b0de8c50020
`
`(
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