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FDA Approves Xyosted for Testosterone Replacement

Antares Pharma news release; 2018 Oct 1

Antares Pharma, Inc. has announced the approval of Xyosted (testosterone enanthate) injection by the US Food and Drug Administration (FDA) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Xyosted is the first FDA-approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. Antares Pharma, Inc., is headquartered in Ewing, NJ.

Dosage/administration: Xyosted has been approved in 3 dosage strengths, 50 mg, 75 mg, and 100 mg.

Adverse reactions: The most commonly reported adverse reactions (>5%) were increased hematocrit, hypertension, increased PSA, injection site bruising, and headache.

Citation:

Antares receives FDA approval of Xyosted (testosterone enanthate) injection for testosterone replacement therapy in adult males. [news release]. Ewing, NJ: Antares Pharma, Inc. October 1, 2018. https://www.antarespharma.com/application/files/2715/3835/7488/XYOSTED_FDA_Approval_Final.pdf. Accessed October 3, 2018.