Tuesday, September 08, 2020 3:53:11 PM
https://www.fda.gov/media/138223/download
The determination is consistent with FDA’s decision to recognize exclusivity for other testosterone replacement therapies that have received exclusivity in the past based on the same general study design (a phase 3 study with a primary efficacy endpoint of the proportion of treated subjects with a T Cavg within the normal range after dose titration was complete).
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