The news article says:
Antares Pharma had applied for approval of the product for men with physician-determined hypogonadism. The prefilled, single-use injector enables patients to self-administer testosterone at home instead of applying a patch or gel, or having an intramuscular injection in a doctor's office.
The FDA identified two safety concerns. First, that Xyosted could cause a clinically meaningful increase in blood pressure, and second, it is concerned about the occurrence of depression and suicidality.
Antares Pharma had applied for approval of the product for men with physician-determined hypogonadism. The prefilled, single-use injector enables patients to self-administer testosterone at home instead of applying a patch or gel, or having an intramuscular injection in a doctor's office.
The FDA identified two safety concerns. First, that Xyosted could cause a clinically meaningful increase in blood pressure, and second, it is concerned about the occurrence of depression and suicidality.
