Nutriband Inc. announced that the United States Food and Drug Administration (FDA) granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). This is a significant step in the regulatory pathway for the product.
The meeting is scheduled as a virtual face-to-face meeting on September 18, 2025, with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP). The purpose is to provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product.
This feedback will cover the plans from the submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA) and subsequent commercialization. Direct engagement with the FDA on these critical aspects helps to clarify the path forward for AVERSA™ FENTANYL.
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