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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 206073/S-011
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Boehringer Ingelheim Pharmaceuticals, Inc.
`Attention: Renee Zindell, M.S., RAC
`Associate Director, Regulatory Affairs
`900 Ridgebury Road; P.O. Box 368
`Ridgefield, CT 06877
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`Dear Ms. Zindell:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received February
`17, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Glyxambi (empagliflozin and linagliptin) tablets.
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`This Prior Approval supplemental new drug application proposes to update the format, font, and
`logo for the trade name of the Glyxambi carton and container labeling.
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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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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the 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 titled Providing Regulatory Submissions in Electronic Format — Certain Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(May 2015, Revision 3). For administrative purposes, designate this submission “Final Printed
`Carton and Container Labels for approved NDA 206073/S-011.” Approval of this
`submission by FDA is not required before the labeling is used.
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`Reference ID: 4137443
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`NDA 206073/S-011
`Page 2
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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 supplemental 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 Michael G. White, Ph.D., Regulatory Project Manager, at
`(240) 402-6149.
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`Sincerely,
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`{See appended electronic signature page}
`
`Jean-Marc Guettier, M.D.
`Director
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling (previously approved on August 10, 2017)
`Carton and Container Labeling
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`Reference ID: 4137443
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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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`JEAN-MARC P GUETTIER
`08/10/2017
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`Reference ID: 4137443
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