Oral Testosterone Therapies Face Clinical Practice Difficulties, Advisory Panels Suggest
FDA's advisory committee voted down Lipocine's Tlando and Clarus' Jatenzo based on concerns about off-label use, but if they do reach the market, Tlando's lack of titration could pose problems for physicians, while both drugs could raise difficulties with the types of tubing used to test testosterone concentrations.
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Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals
The latest US drug development news and highlights from our Performance Tracker.
Tlando's product would offer convenient oral route of administration, but may carry some secondary (endpoint) problems.
US FDA questions Clarus product's long-term safety in briefing documents for Bone, Reproductive and Urologic Drugs Advisory Committee meeting.