Aquestive Therapeutics Inc. · carta de resposta completa (NDA 219870)

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¢ YN U.S. FOOD & DRUG ADMINISTRATION NDA 219870 COMPLETE RESPONSE Aquestive Therapeutics Inc. Attention: Melina Cioffi, PharmD Vice President, Regulatory Affairs 30 Technology Drive Warren, NJ 07059 Dear Dr. Cioffi: Please refer to your new drug application (NDA) dated and received me ; and your amendments, submitted pursuant to oe , for dibutepinephrine sublingual film. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. HUMAN FACTORS AND CLINICAL The results of the human factors (HF) validation study demonstrated several use errors/close calls/use difficulties with critical

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