Lusduna Nexvue Gets Tentative Approval from FDA
Merck announced that the Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection) 100 U/mL, a follow-on biologic basal insulin in a pre-filled dosing device.
Because of its regulatory pathway, Lusduna Nexvue is referred to as a follow-on biologic which is similar, but not identical to an approved reference product. The product has satisfied all regulatory requirements for follow-on biologics regarding safety, efficacy, and quality but is subject to an automatic stay pending the outcome of a patent infringement lawsuit.
Insulin glargine is indicated to treat type 1 diabetes in adults and children, and type 2 diabetes in adults when basal(long-acting) insulin is required.
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