Jatenzo v. Tlando: Similar Issues Did Not Lead To Similar Votes
Two oral testosterone therapies solicited similar concerns, but sometimes different votes from advisory committee members on recommending approval.
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Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals
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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.
Oral testosterone's current clinical data could not definitely exclude elevated blood pressure, panelists vote.