Antares Receives FDA Approval of Xyosted (Testosterone Enanthate) Injection for Testosterone Replacement Therapy

Antares Pharma (NASDAQ:ATRS) today announced the approval of XYOSTED (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). 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.

As quoted in the press release:

XYOSTED^™ has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).

“Today’s FDA approval of XYOSTED is a significant milestone for Antares. XYOSTED expands our branded portfolio of combination drug/device products and continues to highlight our passion and commitment to providing high quality therapies that improve patient care,” said Robert F. Apple, President and Chief Executive Officer of the Company.

Click here to read the full press release.