madman
Super Moderator
Physicians Welcome Testosterone Labeling Changes
Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be removed, the FDA announced.
www.medscape.com
Marius Pharmaceuticals, which markets Kyzatrex (testosterone undecanoate) capsules, indicated further studies of testosterone could be coming.
Shalin Shah, CEO of the company, said in a news release the labeling changes will “accelerate Marius Pharmaceuticals’ research into additional therapeutic uses of testosterone.”
In September, Marius urged regulators to remove the boxed warning on its drug, which was approved in 2022.
“With the removal of this warning, patients and providers can finally have an informed, evidence-based discussion about the true benefits and risks” of testosterone therapy, Shah said.
