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Zdrowie i gospodarka · 02/09/2021

FDA Director Proposes to Refuse Approval of Exenatide-Based Drug ITCA 650

The FDA Director is proposing to reject Intarcia Therapeutics' new drug application for ITCA 650, a version of exenatide in a DUROS device, and offers the company an opportunity to request a hearing on the matter.

Source: Federal Register — Food and Drug AdministrationOpen original release →