Aytu Submits Manufacturing Site Transfer Prior Approval Supplement

 Company Expects a Six-Month Review of the Prior Approval Supplement Submission by the U.S. Food & Drug Administration Which, if Approved, Enables the Transfer of Cotempla Production to Contract Manufacturer

Upon Completion of Manufacturing Transfer of Adzenys XR-ODT and Cotempla XR-ODT, Company Expects to Improve ADHD Product Margins by an Estimated Fifteen Percent

 Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on developing and commercializing novel therapeutics, has submitted the Cotempla XR-ODT® ("Cotempla") Prior Approval Supplement (PAS) to the U.S. Food & Drug Administration (FDA). 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® ("Adzenys") site transfer PAS and has begun shifting Adzenys production to the Company's contract manufacturer.

https://www.biospace.com/article/releases/aytu-biopharma-announces-submission-of-cotempla-xr-odt-r-manufacturing-site-transfer-prior-approval-supplement/