Low T products under FDA scrutiny over safety concerns

"Low T" products are characterized by a variety of different drug delivery technologies and mechanisms. In May, the FDA approved the first nasal gel for low testosterone. And in March, the agency finally approved Aveed as an injection given once to begin therapy, once four weeks later, and every 10 weeks after that. Meanwhile, Clarus Therapeutics has submitted an orally delivered therapy for low testosterone to the FDA and should receive approval (or rejection) by November. Low T products also come with significant safety concerns; after all the FDA rejected Aveed three times before the March approval. Now all the products are under scrutiny. On Sept. 17 the agency is convening an advisory committee meeting to discuss appropriate patient selection and the risk of major adverse cardiovascular events associated with low T products. Meeting information