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Lusduna Nexvue Approval Status

Lusduna Nexvue (insulin glargine injection) is a follow-on biologic (biosimilar) to Lantus in development for the treatment of patients with type 1 and type 2 diabetes.

Development Status and FDA Approval Process for Lusduna Nexvue

DateArticle
Jul 20, 2017Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin
Aug  5, 2016Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
Jun 13, 2016Merck’s Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus®

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