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# Merck Gains Tentative OK for Follow-on Basal Insulin
- URL: https://www.fdaweb.com/merck-gains-tentative-ok-for-follow-on-basal-insulin/
- Published: 2017-07-21T12:00:00.000Z
- Updated: 2026-09-14T22:35:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139188

FDA has granted Merck tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. The proposed product is being developed by Merck with funding from Samsung Bioepis. “With the tentative approval, Lusduna Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement,” Merck says.