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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21462/S-045
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Eli Lilly and Company
`Attention: Guy Ruble, Pharm.D.
`Director, Global Regulatory Affairs - US
`Lilly Corporate Center
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`Indianapolis, IN 46285
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`Dear Dr. Ruble:
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`Please refer to your Supplemental New Drug Application (sNDA) dated May 14, 2013, received
`May 14, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Alimta (pemetrexed for injection), for intravenous use, 100 mg and 500 mg vials.
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`We acknowledge receipt of your amendments dated August 12 and September 11, 2013.
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`This “Changes Being Effected” supplemental new drug application provides for revisions to the
`ADVERSE REACTIONS - Postmarketing Experience section of the package insert to include
`information regarding immune-mediated hemolytic anemia. In addition, the supplement
`provides for revisions to the product title in the HIGHLIGHTS section.
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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
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` 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
`of labeling must be identical to the enclosed labeling text for the package insert 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.
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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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`Reference ID: 3372274
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`NDA 21462/S-045
`Page 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 includes 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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`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 Deanne Varney, Regulatory Project Manager, at (301) 796-0297.
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`ENCLOSURES:
`Content of Labeling (PI and PPI)
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`Reference ID: 3372274
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`Sincerely,
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` {See appended electronic signature page}
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`Jeffery Summers, M.D.
`Deputy Director for Safety
`Division of Oncology Products 2
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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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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`JEFFERY L SUMMERS
`09/12/2013
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`Reference ID: 3372274
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