The US Food and Drug Administration (FDA) has tentatively approved Merck’s Lusduna™ Nexvue ™ insulin glargine injection (100 units/mL), a follow-on biologic basal insulin, according to a press release.
Lusduna Nexvue has met all regulatory standards required for follow-on biologics; however, a lawsuit from Sanofi claiming patent infringement has resulted in “an automatic stay,” potentially delaying final FDA approval for up to 30 months.
Lusduna Nexvue will be available via prefilled dosing devices.
Merck announces U.S. FDA grants tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a follow-on biologic basal insulin [news release]. Kenilworth, NJ: Merck. http://www.businesswire.com/news/home/20170720005270/en/Merck-Announces-U.S.-FDA-Grants-Tentative-Approval. Published July 20, 2017. Accessed July 20, 2017.