`
`NDA 022341/S-029
`
`Novo Nordisk, Inc.
`Attention: Michelle Thompson
`Senior Director, Regulatory Affairs
`P.O. Box 846
`800 Scudders Mill Road
`Plainsboro, New Jersey 08536
`
`Dear Ms. Thompson:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received July 19,
`2017, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Victoza (liraglutide) injection.
`
`This sNDA provides for proposed modifications to the approved risk evaluation and mitigation
`strategy (REMS). This supplement is in response to our July 18, 2017, REMS Modification
`Notification letter.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Victoza (liraglutide) injection was originally approved on January 25, 2010, and
`the most recent modification was approved on September 20, 2016. The REMS consists of a
`communication plan and a timetable for submission of assessments of the REMS. In order to
`minimize burden on the healthcare delivery system of complying with the REMS, we determined
`that you were required to make the following REMS modifications: elimination of the
`communication plan as an element of the REMS.
`
`Because the communication plan has been completed and the assessment demonstrates that the
`communication plan has met its goals, we have determined that it is no longer necessary to
`include it as an element of the approved REMS to ensure that the benefits of the drug outweigh
`the risks.
`
`Therefore, because the communication plan is no longer necessary to ensure the benefits of the
`drug outweigh the risks, a REMS is no longer required for Victoza (liraglutide) injection.
`
`Reference ID: 4130535
`
`
`
`NDA 022341/S-029
`Page 2
`
`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 Marisa Petruccelli, Regulatory Project Manager, at
`(240) 402-6147.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Jennifer Rodriguez Pippins, M.D., M.P.H.
`Deputy Director for Safety
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`Reference ID: 4130535
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JENNIFER R PIPPINS
`07/26/2017
`
`Reference ID: 4130535
`
`
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