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Xyosted FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 9, 2018.

FDA Approved: Yes (First approved September 28, 2018)
Brand name: Xyosted
Generic name: testosterone enanthate
Dosage form: Subcutaneous Injection
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male

Xyosted (testosterone enanthate) is a self-administered, subcutaneous injection formulation of the androgen testosterone for the treatment of male hypogonadism, also known as testosterone deficiency or Low T.

Warning: Blood Pressure Increases
  • Xyosted can increase your blood pressure, which can increase your risk of having a heart attack or stroke, and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke, or if you have other risk factors.
  • If your blood pressure increases while you are on Xyosted, blood pressure medicines may need to be started. If you are already taking blood pressure medicines, new blood pressure medicines may need to be added, or your current blood pressure medicines may need to be changed to control your blood pressure.
  • If your blood pressure cannot be controlled, Xyosted may need to be stopped.
  • Your healthcare provider will monitor your blood pressure while you are being treated with Xyosted.

What is Xyosted?

Do not take Xyosted if:

Before you use Xyosted
Tell your healthcare provider about all your medical conditions, including, if you:

How should I use Xyosted?

Common Side Effects

The most common side effects of Xyosted include:

Development timeline for Xyosted

DateArticle
Oct  1, 2018Approval FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
Apr  5, 2018Antares Pharma Provides Xyosted Regulatory Update
Oct 20, 2017Antares Pharma Receives Complete Response Letter From the FDA for Xyosted
Feb 27, 2017Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot® Testosterone
Dec 21, 2016Antares Pharma Announces Submission of New Drug Application for Quickshot Testosterone

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.