Aytu BioPharma, Inc. announced receipt of U.S. Food & Drug Administration (FDA) approval of the Cotempla XR-ODT® ("Cotempla") Prior Approval Supplement (PAS). This approval enables the transfer of manufacturing of Cotempla to the Company's third-party manufacturer and follows a similar achievement for Adzenys XR- ODT® ("Adzenys") which received PAS approval in April 2023. Aytu is committed to a consistent and orderly transition of production to the new manufacturing facility in the coming months to ensure adequate inventory is available to meet the recent surge in prescription growth experienced for both Adzenys and Cotempla.
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