Aytu Biopharma
2 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
The sponsored links are misleading because they include representations about the efficacy of Adzenys XR-ODT but fail to communicate any risk information.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Sponsored links include efficacy claims but omit any risk information, creating a misleading impression about safety.
Supporting FDA text
Source excerpt · automated text-match checkThe sponsored links are misleading because they include representations about the efficacy of Adzenys XR-ODT but fail to communicate any risk information.
Sponsored links fail to present the established name in direct conjunction with the proprietary name.
Supporting FDA text
Source excerpt · automated text-match checkThe sponsored links fail to present the established name for Adzenys XR-ODT, thereby misbranding the product.
Sponsored links were not submitted to FDA under Form FDA-2253 at the time of initial publication.
Supporting FDA text
Source excerpt · automated text-match checkA copy of the sponsored links was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- List all other promotional communications (with the 2253 submission date) for Adzenys XR-ODT that contain representations such as those described above
- Explain your plan for discontinuation of such communications, or for ceasing distribution of Adzenys XR-ODT
- Include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.