FDA Approves Injection For Testosterone Replacement Therapy In Adult Men

reports the Food and Drug Administration on Monday approved Xyosted (testosterone enanthate), Antares Pharma Inc’s injectable drug to treat low testosterone levels in men, a year after the agency rejected it. The drug comes with the FDA’s strongest boxed warning “flagging risks of a rise in blood pressure that can cause cardiovascular events.” Xyosted is now the “second branded injectable testosterone replacement therapy in the low-T market and could prove to be both a meaningful financial and sentiment catalyst, Raymond James analyst Elliot Wilbur said in a research note ahead of the FDA’s nod.” https://www.reuters.com/article/us-antares-pharma-fda/antares-pharmas-testosterone-drug-gets-fda-approval-idUSKCN1MB2BM