DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 205692/S-005
SUPPLEMENT APPROVAL
Eli Lilly and Company
Attention: Joerg Pfeifer, Ph.D.
Advisor, Global Regulatory Affairs- U.S.
Lilly Corporate Center
Indianapolis, Indiana 46285

Dear Dr. Pfeifer:
Please refer to your Supplemental New Drug Application (sNDA) dated and received
May 5, 2016, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act (FDCA) for Basaglar (insulin glargine injection).
This Prior Approval supplemental new drug application proposes to align the patient package
insert (PPI) of Basaglar with that of Lantus.
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(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, text for the
patient package insert, instuction for use), 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
The SPL will be accessible from publicly available labeling repositories.

Reference ID: 3939421

 NDA 205692/S-005
Page 2

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 markedup 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).
REQUIRED PEDIATRIC ASSESSMENTS
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.
Because none of these criteria apply to your application, you are exempt from this requirement.
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 Callie Cappel-Lynch, Regulatory Project Manager, at
(301) 796-8436.
Sincerely,
{See appended electronic signature page}
Jean-Marc Guettier, MD
Director
Division of Metabolism and Endocrinology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research
ENCLOSURES:
Package Insert (previously approved December 16, 2015)
Patient Package Insert
Instructions for Use (previously approved December 16, 2015)

Reference ID: 3939421

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JEAN-MARC P GUETTIER
06/01/2016

Reference ID: 3939421