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Oral Testosterone Therapy Jatenzo Faces CV, Sampling Tube Issues At Advisory Cmte

Executive Summary

US FDA questions Clarus product's long-term safety in briefing documents for Bone, Reproductive and Urologic Drugs Advisory Committee meeting.

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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.

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.

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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