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Aytu Biopharma Warning Letter Details

Warning Letter

Aytu Biopharma

7900 E. Union Avenue, Suite 920 Denver , CO 80237 United States

Issue DateSeptember 09, 2025

FEI NumberN/A

Violations2

CountryUnited States

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

False & Misleading Claims/Misbranded

Aytu Biopharma FDA Warning Letter, September 9, 2025