NDA 213953, held by Marius. Testosterone Undecanoate.
As of Nov 13, 2026, NDA 213953 (Kyzatrex), held by Marius, was first approved by FDA on Jul 27, 2022, with 1 approved supplement and 1 published complete response letter.
KYZATREX is 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 conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (folliclestimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 22, 2021 | Testosterone undecanoate | Approved |
| Kyzatrex100MG · capsule;oral | Testosterone Undecanoate | DiscontinuedReference drug |
| Kyzatrex150MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Kyzatrex200MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Kyzatrex50MG · capsule;oral | Testosterone Undecanoate | RxReference drug |
| Jul 11, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Jul 27, 2022 | Original applicationNew formulation or manufacturer · 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
