Antares' approved testosterone therapy to carry warning

2 October 2018

A year after being rejected by the US Food and Drug Administration (FDA), New Jersey-based Antares Pharma (Nasdaq: ATRS) has been given the green light by the regulator to market its Xyosted (testosterone enanthate) injection in the USA.

Xyosted becomes 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.

It has been approved in the 50mg, 75mg and 100mg dosage strengths and is the second branded injectable testosterone replacement therapy, targeting a market in which 6.5 million retail prescriptions were filled in 2017.

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