FDA WARNING_LETTER - Aytu Biopharma

Aytu Biopharma (Aytu) received a warning letter from the FDA on September 9, 2025, following an inspection of their promotional communications for COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), conducted as part of the FDA"s monitoring and surveillance program. The inspection revealed that Aytu"s sponsored links for COTEMPLA XR-ODT were misleading and violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations included the omission of critical risk information, creating a misleading impression of the drug"s safety and efficacy. The promotional materials failed to adequately communicate the high potential for abuse and misuse associated with COTEMPLA XR-ODT, a Schedule II controlled substance. Additionally, the links falsely suggested therapeutic equivalence with Concerta, despite differences in dosage form and strength, misleading consumers about substitutability.

The FDA also noted that the sponsored links did not prominently present the established name of the drug alongside its proprietary name, further misbranding the product. Moreover, Aytu failed to submit the promotional materials under Form FDA-2253, as required by FDA regulations.

The FDA has requested Aytu to cease the dissemination of these misleading promotional communications immediately and to submit a comprehensive plan to address these violations. Aytu must ensure future compliance with all regulatory requirements to prevent further misbranding of their products.