FDA Rejects Test E Autoinjector, Xyosted

Jinzang

Member
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.
 

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