Marius Pharmaceuticals, LLC: testosterone undecanoate

During the Agency's inspection of Site 104 to determine whether excluding this site was justified, the site personnel were unable to provide documentation on PK blood sample processing and handling.

Based on the findings at Site 104, the Agency conducted an inspection of Site 107 (South Florida Medical Research, Maitland, FL).

As the integrity and reliability of the PK data from MRS-TU-2019EXT cannot be assured, we cannot conclude that MRS-TU-2019EXT provides substantial evidence of effectiveness for your product.

You need to have adequate documentation of PK sample collection, handling, processing, and storage to verify these steps are carried out according to the prespecified procedures, ensuring the reliability of the PK results.

We reserve further comment on the proposed labeling until the application is otherwise adequate.

'ake before the application may be approved.