It’s not yet clear whether the pharmaceutical industry’s male fountain of youth – widely used billion dollar testosterone treatments – is in jeopardy of collapsing following an advisory panel’s near unanimous recommendations that the drugs’ indication be significantly narrowed and cardiovascular outcomes studies be conducted.
The Next Estrogen Or An Off-Label Star: Can FDA Turn Back The Clock On Testosterone?
Testosterone replacement products took a hit after an FDA advisory committee, but even if the agency follows their advice, panelists worried a label change will not curb use in the now infamous “Low-T” population; meanwhile, a vigorous pipeline of new testosterone formulations may be left in limbo.