FDA advisors voted 18-3 against approval of Clarus Therapeutics Inc.’s oral testosterone treatment Rextoro Sept. 18, citing dosing administration challenges as one of their primary concerns that could affect both efficacy and safety – an ironic outcome since the oral administration is in theory supposed to be a key advantage.
Clarus’ Oral Testosterone’s Perceived Advantage Becomes Downfall At FDA Panel
Oral dosing is “double-edge sword” as unique concerns with Rextoro’s formulation leads to negative advisory committee vote for the testosterone replacement treatment despite panelists’ desire for an oral option.
More from United States
• By
Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
• By
Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
• By
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."