Aytu BioPharma announces FDA approval of Adzenys XR-ODT PAS

Aytu BioPharma received U.S. Food & Drug Administration approval of the Adzenys XR-ODT Prior Approval Supplement. This approval enables the transfer of manufacturing of Adzenys to the Company’s third-party manufacturer. Additionally, the Cotempla XR-ODT bioequivalence study has been successfully completed. Accordingly, the Company expects to submit the Cotempla site transfer PAS to the FDA in the middle of calendar 2023, with approval expected thereafter. The Company expects a six-month review of the PAS, which would enable FDA approval by late calendar 2023 or early calendar 2024.