`
`NDA 206321/S-009
`
`Novo Nordisk, Inc.
`Attention: Patricia Robson
`Senior Manager, Regulatory Affairs
`P.O. Box 846
`800 Scudders Mill Road
`Plainsboro, NJ 08536
`
`Dear Ms. Robson:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received November
`30, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Saxenda (liraglutide) injection, 3 mg.
`
`This sNDA provides for proposed modifications to the approved Saxenda risk evaluation and
`mitigation strategy (REMS). This supplement is in response to our November 26, 2018, REMS
`Modification Notification letter.
`
`We have completed our review of this supplemental application. It is approved effective on the
`date of this letter.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Saxenda was originally approved on December 23, 2014, and the most recent
`modification was approved on May 22, 2017. 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 REMS modifications outlined in our REMS Modification Notification letter dated
`November 26, 2018.
`
`Communication Plan: We have determined that the communication plan is no longer necessary
`as an element of the REMS to ensure the benefits of Saxenda outweigh its risks because the
`communication plan has been completed and because the most recent assessment demonstrates
`that the communication plan has met its goals. No further assessments are necessary to assess
`the current communication plan.
`
`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 Saxenda.
`
`Reference ID: 4358374
`
`
`
`NDA 206321/S-009
`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 Martin White, M.S., Regulatory Project Manager, at
`(240) 402-6018.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`William Chong, M.D.
`Deputy Director (Acting)
`Division of Metabolism and Endocrinology
`Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`Reference ID: 4358374
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`WILLIAM H CHONG
`12/04/2018
`
`Reference ID: 4358374
`
`(
`
`
`
`
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