NDA 209863, held by Antares Pharma Inc. Testosterone Enanthate.
As of Nov 13, 2026, NDA 209863 (Xyosted (Autoinjector)), held by Antares Pharma Inc, was first approved by FDA on Sep 28, 2018, with 2 approved supplements and 1 published complete response letter.
XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2018 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 20, 2017 | Testosterone enanthateClinical | Approved |
| Xyosted (Autoinjector)50MG/0.5ML (50MG/0.5ML) · solution;subcutaneous | Testosterone Enanthate | RxReference drug |
| Xyosted (Autoinjector)75MG/0.5ML (75MG/0.5ML) · solution;subcutaneous | Testosterone Enanthate | RxReference drug |
| Xyosted (Autoinjector)100MG/0.5ML (100MG/0.5ML) · solution;subcutaneous | Testosterone Enanthate | RxReference drug |
| Jul 11, 2025 | Supplement 20Labeling · Standard review | Approved | |
| Nov 19, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Sep 28, 2018 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
