Surprise Approval For Clarus' Oral Testosterone Includes Black Box, No REMS
Jatenzo clears US FDA 15 months after second negative advisory committee review.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Studies are unfeasible, sponsors argue in advance of US advisory committee meeting that could lead to FDA ending its waiver on requiring clinical trials in pediatric patients for new testosterone replacement therapy products.
Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go in approving new entrants to a market with widespread historic off-label use and CV risks.