Oral Testosterones Might Use REMS, CV Post-Market Study To Win Approval
US FDA advisory committee worries about off-label use of Lipocine's Tlando and Clarus' Jatenzo.
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Jatenzo – the first oral testosterone cleared by US FDA – will compete against injectable and topical formulas in a field that has suffered safety worries in the past. Clarus has a jump on oral rival Lipocine.
As agency embraces bullet-point format, old-school draft full of call-outs and solicitations seems unlike anything before or since. Regardless of style, FDA's testing recommendations for developmental therapies are of broad, substantive interest to industry.
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.