Aytu BioPharma submits Cotempla XR-ODT PAS to FDA

Aytu BioPharma has submitted the Cotempla XR-ODT Prior Approval Supplement to the U.S. Food & Drug Administration. If approved, the PAS would enable Aytu to transfer the production of Cotempla to the Company’s third-party manufacturer. The Company expects a six-month review of the PAS submission, which would enable FDA approval by late calendar 2023 or early calendar 2024. The Company previously announced the FDA approval of the Adzenys XR-ODT site transfer PAS and has begun shifting Adzenys production to the Company’s contract manufacturer.